FDA Regulatory Manager, Drug Submissions
Exponent Inc.
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 Exponent Inc.
$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$110k - $158k
# Regulatory Affairs, Senior Manager Obesity and Related ConditionsBioSpaceFull TimeseniorWashington... ...and lead U.S. regulatory submissions (e.g., clinical trial and... ...submissions and direct FDA interaction, with strong... ...environment and drug development lifecycle.* Experience...SuggestedFull timeWorldwideFlexible hours- ...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
$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...SuggestedFixed term contractWork at officeLocal areaWorldwide3 days per week- ...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
$83k - $90k
...This position reports to the General Manager and is responsible for monitoring all aspects... ...trip databases, vehicle inspections, and submission of various reports on service quality. Must... ...and contractual requirements such as FTA drug/alcohol testing standards and additional...Contract workTemporary workWork experience placementLocal areaRemote workLong distanceFlexible hoursShift work- Overview The Director, Regulatory Science and Policy, works closely with... ...in areas that are focused on FDA‑related issues. The Director,... ...development of two or more novel drugs, informing regulatory science,... ...Science and Policy, will manage a team of employees, work on a...Work at office
- EY in McLean is seeking a Senior Manager for their Life Sciences Regulatory Submissions practice. This role involves leading client engagement teams, driving regulatory... ...in Regulatory Affairs, a deep understanding of the FDA process, and proven leadership skills to build and...Flexible hours
$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,...Full timePart timeWork experience placementImmediate startWorldwide$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- TryApplyNow is seeking a Senior Manager of Regulatory Affairs for Obesity and Related Conditions in Washington, D.C. This full-time role involves developing regulatory strategies and overseeing U.S. submissions for clinical trials and marketing applications. The successful...Full time
- ...The Scientific Program Manager will provide support to... ...Responsibilities: Serve as a regulatory affairs management... ...an Investigational New Drug (IND) application... ...and Drug Administration (FDA) regulations for use of... ...implementation, review processes, submissions and compliance with the...Contract workWork at office
$157.2k - $256.6k
...Director, Global CMC Regulatory Strategy As an Associate... ...input from senior management. Represent CMC RA at... ..., and marketing of drugs and/or biologics. Lead... ...impact and associated submission requirements for... ...interacting with the US FDA and other regulatory authorities...Work at officeRemote workWorldwideRelocation package3 days per week$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$132k - $209k
...Federal Contracts & Subcontracts Manager - Compliance/Governance (... ...operational capabilities. Provide pre-submission compliance guidance and... ...peaks, and stay current on regulatory changes, industry trends, and... ...Disability/Vets and maintains a drug-free workplace....Full timeContract workWork at officeImmediate startWork visa3 days per week$94k - $160k
Policy & Regulatory Affairs Manager Hybrid in Washington D.C. Join us in shaping a healthier future for kids. At Children’s Hospital Association, we unite more than 200 member hospitals to put children first—advancing care, informing policy, and driving progress together...Work at officeRemote work- 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 enabling...
- ...Washington DC, you will lead Blue Origin's Regulatory Affairs function, engaging strategically... ..., overseeing policy-related projects, managing federal and state agency interactions,... ...onboarding), Road Test, Hours of Service, Drug and Alcohol Testing (CDL drivers only),...Permanent employmentTemporary workLocal area
- ...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
- ...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
$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$119.25k - $204.4k
...Role Total Wine & More seeking a Senior Manager, Compliance to join our HR Compliance team... ...procedures to ensure adherence to legal and regulatory requirements. This role involves... ...interview process. Total Wine & More is a Drug Free Workplace. The information provided...Work at officeLocal area- ## Legislative and Regulatory Senior Policy Program ManagerApplylocations: US DC 9th St NWtime type: Full timeposted on: Posted 12 Days... ...expertise in Medicaid policy, including knowledge of Medicaid managed care, federal-state financing structures, delivery system and...Work experience placementShift 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...
$41 - $65.6 per hour
...Full Time Summary The Compliance Program Manager is responsible for the development, implementation... ...for monitoring and responding to certain regulatory requests and representing the Compliance... ...Health System and its affiliates are drug‑free workplace employers. Johns Hopkins...Full timeWork experience placementLocal areaDay shift$100k - $117k
...information, visit MEMA's official site. The Opportunity The Senior Manager, Regulatory Affairs is an integral member of MEMA’s Government Affairs... ...vehicle supplier industry. Facilitate the development and submission of regulatory comments. For technical issues, this includes...Work at office- Compliance Manager, Corporate Compliance Location: Arlington, VA Role Overview The Compliance... ...program and daily screening. Monitor regulatory developments and enforcement trends and... ...coverage (Medical, Vision, Dental, Prescription Drug). Life, legal and supplementary...Local area
$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$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
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