Director Of Regulatory Affairs Jobs in the United States

MastarRec

NYC, NY

The Director of Regulatory Affairs leads external regulatory engagement, licensing strategy, and regulatory change management for a US FinTech. This role ensures the organisation remains ahead of regulatory developments and maintains strong, credible relationships with oversight bodies.

CEDENT

undefined, MD

Summary:The Director of Regulatory Affairs is responsible for overseeing regulatory compliance initiatives to support patient safety and quality, ensuring adherence to Federal, State, and local regulations. Coordinate virtual and onsite surveys by external regulatory and accreditation agencies, as well as mock surveys by consultants or internal teams.

Coyote Technical & Executive Sourcing

Fairfield, CT

Minimum Experience: 15 years of Quality Assurance, Quality Engineering, and Regulatory experience in a FDA regulated environment, preferably Medical Devices, Gastrointestinal. Hands-on Director who is responsible for the Regulatory Affairs and Quality Assurance strategy, policies, and procedures to ensure we follow all domestic and international guidelines and regulations.

Caldera Medical

$150000 - $176000

Westlake Village, CA

The Director of Regulatory Affairs will lead global regulatory strategy, manage submissions, obtain necessary licenses and approvals, and ensure compliance with U.S. and international regulations including FDA, EU MDR/MDD, MDSAP, NMPA, TGA, and other global regulatory bodies. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal.

ChromoLogic

$130000 - $170000

Monrovia, CA

Covisus Inc. (www.covisus.com) is a VC-funded spin-off from ChromoLogic that has developed an award-winning and industry-leading technology for tagless tracking of assets based on its vTag® technology. Develop and implement quality assurance strategies and regulatory compliance programs (FDA 510(k), PMA, IDE, drug approval, IND, pre-submission).

Hamilton Medical, Inc.

Reno, Nevada

Proven track record of authoring, reviewing, and approving high-quality 510(k) submissions, including substantial equivalence arguments, intended use, labeling, and responses to FDA deficiencies. Lead and oversee all formal FDA engagements, including Pre-Submissions (Q-Subs), submission meetings, interactive reviews, deficiency responses, and appeals.

Systimmune

Princeton, NJ

The Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure.

Monte Rosa Therapeutics, Inc

Boston, Massachusetts

Overview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.

Kymera Therapeutics

$160000 - $275000

Watertown, MA

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. As a critical member of a growing RA organization, this role will leverage their recent and relevant hands-on experiences developing immunology treatments to help rapidly advance Kymera's I/I portfolio of targeted protein degraders.

Septerna

$235000 - $260000

South San Francisco, CA

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission.

Systimmune

Redmond, WA

The successful candidate will set regulatory direction, guide cross-functional teams, and ensure high-quality IDE and PMA submissions, while remaining sufficiently hands-on to provide technical oversight and mentorship when needed. We are seeking a Regulatory Affairs leader at the Associate Director or Director level to lead IHC-based Companion Diagnostics (CDx) regulatory strategy and execution in support of our oncology ADC pipeline.

Soleil Labs, LLC

$200000 - $270000

South San Francisco, CA

This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil). This individual will oversee both Clinical and CMC regulatory functions, providing strategic and operational leadership across IND/CTA submissions, clinical development programs, and CMC activities.

Cardinal Health

$135400 - $228910

Olympia, WA

Qualifications** + 15+ years of pharmaceutical industry experience, including 10+ in regulatory affairs preferred + Bachelor's degree preferred; MS, PharmD, or PhD preferred + Experience in a consulting environment + Strong business acumen and team leadership skills, developing and growing a consulting team + Deep technical knowledge of regulatory requirements (FDA, EMA, ICH, GLP, GMP, GCP) + Strong written, verbal, and cross-functional communication skills + Proven ability to lead and develop teams, especially consulting or matrixed environments + Ability to travel up to 25% + Leadership Attributes: + Strategic and enterprise-minded leader with a collaborative style. **Position Summary** For nearly five decades, Cardinal Health Regulatory Sciences' industry-trained regulatory consultants have provided expertise and guidance to help pharmaceutical, biotechnology and medical device companies get their products to market.

Xeris Pharmaceuticals, Inc.

$170000 - $220000

Chicago, Illinois

Develop and create CMC regulatory strategy for integrated development plans and long-term planning at a cross-functional level for product(s), consistent with the corporate and project objectives. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need.

Umoja Biopharma

$253000 - $312500

Seattle, WA

We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. This role will develop and implement regulatory strategies leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and other unmet medical needs.

Travere Therapeutics

San Diego, CA

This role will work collaboratively across various functions including Regulatory Affairs, Clinical Development, CMC, Clinical Pharmacology, Clinical Supply (CS), Medical Affairs/Medical Information, Medical Writing, Pharmacovigilance, Quality Assurance (QA), and legal as well as external vendors (as required) to ensure appropriate content and quality control checks are proceduralized and implemented for all labeling activities including Company Core Data Sheets (CCDS), Structured Product Labeling (SPL), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), Instructions for use (IFUs), medication guides, annotated labels and their associated Patient Labeling Documents to support initial Marketing Authorization and lifecycle updates (e.g., new indications, efficacy data, product quality change Responsibilities: Direct and ensure effective execution of optimal strategies for labeling development by providing global labeling insight, developing and implementing harmonized labeling processes for new product labels and associated life-cycle activities, and tracking/maintaining labeling documents. In this role, the Senior Director role requires a solid understanding of global labeling requirements, labeling platforms, label tracking, change control, and print production processes to effectively manage end-to-end label creation and implementation.

Bristol Myers Squibb

$241768 - $293000

Indianapolis, IN

Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb

$173350 - $210100

Princeton, NJ

Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area. Description: The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.

Kura Oncology

$226495 - $258817

Boston, MA

Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML").

Akebia Therapeutics

$246330 - $333270

Cambridge, MA

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them. Base pay is only one component of the company’s total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity.

Zoetis US

Kalamazoo, Michigan

The successful candidate will be the regulatory strategy lead for US FDA regulated products, providing guidance and technical support for new product registrations and supplemental claims as a part of global veterinary pharmaceutical and biopharmaceutical development project teams. To accomplish these responsibilities, the candidate will work closely with colleagues across Veterinary Medicine Research and Development (VMRD) and Global Portfolio Marketing (GPM) to facilitate product development, approval and maintenance consistent with the company operating plans and the project portfolio.

Beam Therapeutics

$260000 - $320000

Cambridge, MA

Hybrid role – some telecommuting permitted, but must work onsite in Beam Therapeutics' Cambridge, MA office most of the time (at least three days per week); Must live in the City of Cambridge, MA, or within a reasonable, daily commuting distance thereof (e.g., areas contemplated can include the City of Boston, the larger Greater Boston region, or Massachusetts' MetroWest, North or South Shore communities); This is because Beam headquarters at 238 Main Street, Cambridge, MA 02142, this is the primary worksite for the role long-term; and. The required five years must also include at least one year of experience (which may have been gained concurrently) involving: Regulatory affairs work within biotechnology specifically, including application of U.S. and global regulatory procedures and practices; Developing regulatory documents and submissions such as IND, CTA/IMPD, BLA, MAA and PIP; and.

Axsome Therapeutics

$160000 - $215000

New York City, NY

Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members.

OneBlood

Orlando, Florida

Ten (10) or more years of progressively responsible management experience in quality & regulatory affairs, preferably in a blood bank environment; or an equivalent combination of education, certification, training, and/or experience. Bachelor’s degree in medical technology, healthcare, chemistry, biology, biotechnology or related field from an accredited college or university; Master’s degree preferred.

Bristol Myers Squibb

$244110 - $295806

Princeton, NJ

Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee, providing strategic guidance and hands-on execution in the design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies—enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time. Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality by delivering timely, strategic guidance in health authority engagements and policy review—ensuring diverse expertise is integrated to drive precision medicine innovation.

Truvian Sciences

San Diego, CA

The ideal candidate must have extensive experience in the in vitro diagnostics (IVD) industry, with a strong track record of leading both FDA 510(k) and CLIA Waiver submissions through to successful clearance. This leadership role will be responsible for supporting regulatory submissions and product registrations across domestic and international markets, ensuring compliance with applicable regulations, and enabling timely product commercialization.

MUSC

Charleston, South Carolina

Collaborates with leaders to establish operating procedures, enhance clinical and non-clinical workflows, increase productivity, and improve overall quality outcomes and operational efficiencies within a variety of delivery settings. Manages and influences relationships with senior management team, administrators, functional area managers and staff to achieve best in practice performance and business results.

Edgility Search

$120000 - $150000

Sacramento, CA

The position is expected to participate in regular travel (mostly in California) including the following engagements: twice yearly Board of Directors meetings (sometimes held in Sacramento); annual 2-3 day staff retreat; annual 3-day Housing California conference (often in Sacramento); annual 2-3-day statewide RUN summit (sometimes in Sacramento); plus various conferences or in-person partner meetings, based on need and interest. We bring together a diverse, cross-sector network to prevent and end homelessness, increase the supply of safe, stable, affordable homes, and reverse the legacy of systemic racial and economic inequities by building power among the people most impacted by housing injustice, shaping the narrative, and advocating for the passage of transformative statewide policy solutions.

Relay Therapeutics

Cambridge, MA

Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. You will work side by side with your regulatory and research and development colleagues to develop​ and execute innovative regulatory strategies for our fast-paced programs, including the implementation of non-clinical and clinical regualtory strategy for relevant products.

Sumitomo Pharma

$156000 - $195000

Olympia, WA

nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed + Advises team members of potential regulatory issues and provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities + Contributes to regional health authority meetings, and briefing book documentation to Health Authorities + Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed. **Job Duties and Responsibilities** + As a Regional Regulatory Lead, manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT) + As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs + Supports and/or leads documentation of regulatory authority interactions including decisions and outcomes + Leads and coordinates project team members in developing strategy for applicable documents/ activities.

Oscar Health

$218592 - $286902

Washington, DC

Work Location: You must reside in one of the following states: Arizona, California, Colorado, Connecticut, D.C., Florida, Georgia, Illinois, Iowa, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York City, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, or Utah. You will advise senior leadership and work closely with teams across the organization to ensure clinical operations align with policy and regulatory intent.

Chemours

$169344 - $264600

Des Moines, IA

The responsibilities of the position include, but are not limited to, the following: + Demonstrate a high degree of knowledge about the political, economic, and social factors affecting public policy decision making; how engagement with government officials can lead to the enactment of new or the modification of existing regulations; implement policies and take other governmental actions that are favorable to Chemours’ business growth, corporate well-being, and the industry sectors in which the company operates. The successful candidate will join Chemours’ Global Government Affairs Group with a primary responsibility for supporting U.S. federal regulatory affairs engagement with the United States Environmental Protection Agency (USEPA), as well as other select federal administrative agencies; key trade organizations that help shape regulatory policies at the U.S. federal level; and members of the U.S. Congress and their staffs.

SK Life Science, Inc.

Paramus, New Jersey

Overview: A Director, Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) Strategy is a leadership role within Regulatory Affairs responsible for the global regulatory strategy and execution related to the pharmaceutical quality and manufacturing of drug products. Cross-Functional Collaboration: Partner with Quality Assurance, CMC and Clinical Supply, R&D to ensure compliance with cGMP (current Good Manufacturing Practices) and assess the regulatory impact of CMC development plans and manufacturing changes.

Hut 8

Miami, FL

You will engage with federal and state policymakers, regulatory commissions, economic development authorities, and industry stakeholders to anticipate policy shifts and advocate for outcomes that accelerate interconnection, support large-load energy development, and enable competitive data center growth. Design and pitch new products, services, and other initiatives to a leadership team consisting of serial entrepreneurs and seasoned executives and backed by a board of directors consisting of industry veterans of energy, finance, and government.

Beth Israel Lahey Health

Boston, MA

Collaborates with the central BILH Information Systems department to ensure adequate electronic systems are in place to capture the data required for submission to regulatory required registries such as UNOS, SRTR, the Joint Commission and INTERMACs. The Manager of Business and Regulatory Affairs oversees financial performance, regulatory compliance, and data management of the Heart Transplant, LVAD and ECMO programs and programs related to Advanced Heart Failure.

Kriya Therapeutics

Research Triangle Park, NC

The Associate Director, Regulatory Affairs (CMC) possesses strong leadership skills, broad knowledge of multiple aspects of regulatory affairs (beyond CMC) across all phases of drug development, and a deep understanding of global CMC regulations, including GMP and region-specific guidelines, especially as they relate to gene therapies. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

HCA Healthcare

Nashville, TN

Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more. This role is responsible for maintaining a comprehensive Quality Management System (QMS), leading hands-on inspection and testing protocols to ensure product reliability and spearheading the design and execution of global regulatory strategies.

Gan & Lee Pharmaceuticals

null, NJ

Demonstrated experience managing interactions with major health authorities (FDA, EMA, MHRA, etc.), including leading Scientific Advice and procedural communications (CHMP/CAT/PRAC). Lead or actively participate in cross-functional teams, including CMOs, global regulatory teams, submission teams, and product development teams, to ensure compliance with applicable U.S. and EU regulatory requirements.

Jacobs Management Group

$196500 - $245600

Lakewood, CO

My client is seeking a visionary regulatory leader to champion compliance systems, elevate global labeling strategy, and guide complex submissions that directly impact patients worldwide. Step into a high-impact leadership role shaping global regulatory strategy for life-sustaining blood and cell technologies.

KPMG LLP

$167700 - $310900

Dallas, TX

If you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory. Additional details about our benefits can be found towards the bottom of our KPMG US Careers site at "Benefits & How We Work Follow this link to obtain salary ranges by city outside of CA: https://kpmg.com/us/en/how-we-work/pay-transparency.html/?id=M128_2_25

Pacira Pharmaceuticals, Inc.

Parsippany, New Jersey

Establish and oversee formal processes to provide regulatory support in the development, revision, review, and approval of labeling content for submission to Health Authorities (USPI, EU PI, and ROW labeling, as well as the internal Company Core Data Sheet). The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.

United Therapeutics

$165000 - $225000

Dover, DE

12+ years of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic or pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or a related area of study. We are focused on the research and development of transplantable kidneys ( mirokidney® ), livers ( miroliver® ), and a bioengineered external liver assist device for acute liver failure ( miroliver_ELAP_® ), with plans to also bioengineer other critical organs like lungs, pancreases and hearts.

ADM

$161400 - $300700

Chicago, IL

The H&W portfolio includes microbiome solutions and specialty health products and ingredients such as prebiotic dietary fibers, plant- and nutritional oils, mixed tocopherols and vitamin E, sterols, sterol esters, isoflavones, natural preservation systems, etc. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments — environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career.

Kemin

Off-site, undefined

Overview: The Regulatory & Scientific Affairs Director is responsible for leading the business units’ regulatory affairs (RA) and quality assurance (QA) teams by proactively ensuring regulatory and quality compliance, scientific integrity, and managing regulatory/quality risks and opportunities aligned with strategic direction and priorities of the business. Qualifications: Education and Experience:Advanced degree (MS, PhD, DVM, or JD) in a scientific, technical, or regulatory field strongly preferred, with 10+ years of progressive leadership experience in regulatory affairs, quality assurance, or compliance within pharmaceuticals, nutraceuticals, biotechnology, or food ingredient industries.

Avalyn Pharma

$163000 - $182000

Boston, MA

This is a critical role for a highly motivated regulatory leader with experience in rare disease drug development, combination products, and a proven track record of advancing programs from early stages through late-phase clinical development. Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease.

Grid United

Houston, TX

Established in 2021 by proven industry leaders, Grid United is developing utility-scale electric multi-state transmission projects that will provide long-term economic benefits to communities across the country, provide Americans with improved grid resiliency for our homes and businesses, and cost savings for electricity consumers. Grid United is a mission-driven company aiming to solve the largest barrier to a more reliable, resilient and affordable grid by developing new long haul electric transmission lines in the United States.

Lingo Staffing

Taylors, SC

The Director of Tax, Compliance & Legal Affairs is a senior leader responsible for overseeing the company’s tax, regulatory, compliance, and corporate legal functions across real estate acquisitions, tax equity, financing, and asset management. The Director oversees internal legal compliance, collaborates with outside counsel, and provides strategic guidance to the executive team while supporting complex real estate transactions and investment activities.

USA The Nature Conservancy

Wyoming, Michigan

The WY Director of External Affairs leads the Business Unit's (BU) external affairs functions, implements BU policy strategies, and provides guidance to program directors and staff on TNC's conservation policy priorities. The WY Director of External Affairs works with government and business entities to further the BU's mission in support of conservation policy and climate action and on behalf of TNC's North America Policy and Government Relations (NAPGR) policy goals.

GridMatrix

$125000 - $145000

Austin, TX

Drive GridMatrix's applications for grants, to RFPs, Trade Missions, and accelerators, coordinating the process from origination to submission and leading a cross functional team of customers, partners, government relations firms, policy organizations, GridMatrix government affairs, and engineering contributors. As the VP/Director of Government Affairs, you will be responsible for crafting and communicating the impact a GridMatrix deployment can have in a community and how this impact supports each of these goals within the context of broader state, local, national, and global regulatory frameworks.

Quaker Houghton

Conshohocken, PA

Support chemical regulatory activities related to documentation including updating raw material information, communicating changes to raw material classifications, data management and updating the SDS system. Supports the Product Stewardship organization globally with responses to key stakeholders including regulatory inquiries, SDS authoring, and answering regulatory inquiries.