FDA Regulatory Manager, Drug Submissions
Exponent
Exponent Inc. is seeking a Manager-level FDA Regulatory Scientist for our Chemical Regulation and Food Safety Practice in Washington, DC. This role involves managing projects related to FDA drug applications, requiring extensive regulatory knowledge and communication skills. The ideal candidate will have a Master’s or Ph.D. in a science-related field and five years of regulatory experience. You will engage with clients and regulators, provide strategic input, and manage project deliverables while working in a collaborative environment. Salary is competitive, and the total compensation includes a base salary, bonuses, and 401(k) contributions. Join us to make a difference in a dynamic workplace! #J-18808-Ljbffr
$176k - $220k
...quality of high‑stakes regulatory documents to support U... .../nicotine product submissions and lifecycle obligations... ...communication with the FDA and other external... ...data display, reference management) and plain‑language communication... .... The U.S. Food and Drug Administration has...Suggested- ...ProPharma Group, LLC is looking for a Director, Regulatory Sciences to oversee projects for US... ...across functions to ensure successful submissions. Ideal candidates will have over 7 years... ...industry, with a deep understanding of FDA regulations. #J-18808-Ljbffr...Suggested
- ...worldwide. Position United States Regulatory Senior Manager – Obesity and Related... ...and lead U.S. regulatory submissions (e.g., clinical trial and marketing... ...submissions and direct FDA interaction, with strong... ...regulatory environment and drug development lifecycle. Experience...SuggestedWorldwide
$135.3k - $376.8k
## Director, Regulatory Affairs – Regenerative Medicine... ...regulatory strategy and submissions for the firm’s... ...responsibilities include managing the development of regulatory... ...Affairs related to FDA oversight of various... ...medical products (HCT/Ps, drugs and/or biologics,...SuggestedFull timePart timeWork experience placementImmediate startWorldwide- ...worldwide. It's time for a career you can be proud of. Regulatory Affairs Senior Manager Regional Regulatory Lead Job Description How might you defy... ...and risk assessments; executes regulatory strategy for submissions; complies with RA CMC processes; identifies needs for...SuggestedOngoing contractLocal areaWorldwideFlexible hours
$165k - $220k
...health in the future. The Director, Regulatory Affairs leads global regulatory... ...regulatory leadership for ophthalmology drug and combination product programs from... ...authority interactions, ensure highquality submissions, and manage regulatory risk across the product...Temporary workWork visa- ...Director, Regulatory Science And Policy The Director, Regulatory Science... ...in areas that are focused on FDA-related issues. The... ...development of two or more novel drugs, informing regulatory science,... ...Regulatory Science and Policy will manage a team of employees, work on a...Work at office
- ...deep domain expertise in regulatory sciences, clinical... ...partners’ most high‑profile drug and device programs.... ...science clients, managing a team of professionals... ...regulatory strategies, submissions, and other deliverables... ...In‑depth knowledge of FDA regulations,...Contract work
$151k - $314k
...Head of US Regulatory Affairs Advertising and Promotion page... ...primary contact with the FDA’s Office of Prescription Drug Promotion (OPDP) within the... ...Administration; lead submissions, risk mitigation strategies... ...improvement initiatives.* Management of a 4–5-member team including...Fixed term contractWork at officeLocal areaWorldwide3 days per week$94k - $160k
...Policy & Regulatory Affairs Manager Hybrid in Washington D.C. Where You’ll Work This position is based in our Washington D.C. office. We leverage a hybrid working model working three days in the office, two days optional remote work. What You’ll Do This position will...Work at officeRemote work$112k - $236k
...Director, Global Regulatory Strategist -Allergy/Cardiovascular Portfolio... ...is communicated to Senior Management and any risks (from emerging... ...are met for all submissions and Health Authority interactions... ...projects across all aspects of drug development and commercial manufacturing...Temporary workWork at officeLocal areaWorldwide- ...OpenAI is looking for an experienced Regulatory & Product Assurance IC to enhance its Governance, Risk, and Compliance (GRC) function across product launches and regulatory readiness. You'll partner with various teams to ensure compliance claims remain accurate while...
$112k - $236k
Director, Regulatory Strategist Develop Global/Regional regulatory strategies... .... Develop fit‑for‑purpose submission packages in collaboration... .... Proven experience in managing global and/or regional regulatory... ...registration activities involved in drug development and/or post‑...Work at officeLocal area2 days per week$248k - $310k
...This role combines senior‑level regulatory policy leadership, regulatory... ...and credibility with FDA and key stakeholders. The... ...strategies. Lead development and submission/socialization of Teva comment... ...FDA programs, and the Food, Drug, & Cosmetic (FD&C) Act, the Public...Local areaRemote workWorldwideFlexible hours- ...IQVIA LLC is seeking a Director, Regulatory Affairs - Neurology MedTech in Washington, DC. This role involves managing regulatory submissions and developing strategies for medical device innovation. The ideal candidate will have at least ten years of experience in Regulatory...
$150k - $175k
...and hold primary responsibility for the comprehensive financial management of MACPAC. Your role will be pivotal in ensuring the... ...data . Reviewing monthly financial reports for accuracy before submission to OMB, Congress, and Treasury. Overseeing the procurement process...Full timeTemporary work$107.8k - $300.4k
## Associate Regulatory Affairs Director, SpineApplylocations... ...strategy and submissions for the firm’s clientele... ...responsibilities include managing the development of... ...development of medical devices, drugs and/or biologics,... ...regulations (e.g., FDA, Notified Body, ISO 13...Full timePart timeWork experience placementImmediate startWorldwide- ...mission and drive solutions. Identifies and analyzes proposed regulatory and legislative initiatives at the federal and state level which... ...expertise in Medicaid policy, including knowledge of Medicaid managed care, federal-state financing structures, delivery system and...Work experience placement
$118.4k
...JOB SUMMARY This job will provide direction and oversight to staff members for the end-to-end operations management of Highmark’s traditional and innovative drug value strategy for all segments. The incumbent leads a team of non-clinical personnel, coordinating the execution...Full timeFor contractorsWork at officeLocal areaRemote work- ...AirPlus is looking for a full‑time US Based Compliance Manager to serve as the Regulatory and Compliance lead and legal counsel for the U.S. entity... ...of regulatory licensing, registration, and regulatory submissions , in coordination with Group and local stakeholders....Full timeContract workLocal areaWorldwide
$145k - $200k
...The tax and regulatory compliance manager serves as a member of the management team of the Office of the Chief Financial Officer. The Manager provides... ...preparation, review, and filing of complex returns and submissions; oversees compliance calendars; and recommends cost-...Work at officeLocal areaWeekend workAfternoon shift- ...Compliance Manager, Corporate Compliance Location: Arlington, VA | Monday-Friday Company... ...compliance program and daily screening. Monitor regulatory developments and enforcement trends and... ...: Medical, Vision, Dental, Prescription Drug. Life, legal, and supplementary insurance...Full timeLocal areaMonday to Friday
$146k - $156k
# Regulatory Compliance ManagerHarvey NashContractmidArlington, Virginia, US$146k – $156kPosted Yesterday## Role OverviewHarvey Nash is hiring a mid-level Regulatory Compliance Manager. This is a contract role in Arlington. posted yesterday. The posted range is $146k to...Contract work$167.92k - $251.88k
## Regulatory Compliance Manager US AntiboycottApplyremote type: Hybridlocations: Washington District Of Columbia United States: Charlotte North Carolina United Statestime type: Full timeposted on: Posted Todaytime left to apply: End Date: July 12, 2026 (25 days left to...Full timeLocal areaFlexible hours- ...Yesterdayjob requisition id: JR5889The role is responsible for managing the day-to-day pharmacy financial and audit operations. This role... ...manages and oversees financial aspects of over $6 Billion in yearly drug spend, ensuring vendors comply with all contractual performance...Contract workWork experience placementLocal areaShift work
- ...Alfasigma is looking for a Manager, Regulatory Lead to join their team in Washington, DC. This role emphasizes developing and implementing regulatory strategies for clinical studies while ensuring compliance with regulatory requirements. The ideal candidate will hold a...Remote work
- ...The Alaska Department of Law is seeking a Program Manager for Regulatory, Federal Affairs in Washington, DC. This hybrid position includes responsibilities such as collaborating with program staff on regulatory compliance, drafting media materials, and developing relationships...
- ...Consultant | Military Spouse Are you a regulatory affairs expert with a strong... ...strategic priorities. The Director will manage complex issues, frame narrative, and... ...Protection Agency (EPA) and Food and Drug Administration (FDA) arenas related to food and beverage,...Full timeTemporary workWork at office
- ...with initial customer deliveries beginning in 2028. Director of Regulatory Affairs Radiant is seeking a highly engaging and effective... ...completeness, timeliness, and quality of licensing and regulatory submissions. Integrate our regulatory process with technical teams to...Full timeSummer workImmediate startRemote workFlexible hoursWeekend work
$110.5k - $151.9k
...Director Science And Regulatory Advocacy Pharmaceutical Research... ...as regulatory bodies (e.g., FDA), sister industry associations... ...candidate will have a background in drug development, regulatory... ...audience. ~ Strong project management experience with the ability to...Shift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to FDA Regulatory Manager, Drug Submissions. Be the first to apply!
- head compliance Washington DC
- director global regulatory affairs Washington DC
- regulatory affairs manager pharmaceutical Washington DC
- finance compliance manager Washington DC
- regulatory manager Washington DC
- compliance manager Washington DC
- regulatory affairs manager medical devices Washington DC
- manager regulatory affairs Washington DC
- regulatory affairs director Washington DC
- compliance director Washington DC

