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- ...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 PPG US ProPharma...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
$79.1k - $166.1k
...Job Description Senior Regulatory Program Manager Location: Telecommuting/remote from within... ...teams to organize and support pre-market submissions and current registrations.... ...occupational health mandates, and/or drug testing requirements. Range and benefit...SuggestedTemporary workRemote workFlexible hours- ...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...SuggestedWork at office
$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 lifecycle...Temporary workWork visa$90k - $105k
...About the Position:The Regulatory Affairs Manager will oversee assigned regulatory team staff, navigate submission/approval pathways, lead the development of new protocol submissions... ...preferred.3-5 years experience in FDA-regulated clinical trials preferred.1-2 years...Work experience placementRemote workFlexible hours$187.52k - $234.4k
...position of Director, Regulatory Advertising & Promotion... ...codes of practice (e.g., FDA regulations, PhRMA... ...ensure on-time and accurate submission of applicable materials... ...Office of Prescription Drug Promotion (OPDP) at FDA... ...procedures. Manage and Develop Talent ~...Work at officeWorldwide$150.03k - $224.25k
...critical support in developing global regulatory strategy, planning and execution of... ...investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned... ..., and guidelines including FDA, ICH, etc. Able to successfully interpret...Temporary workWork at officeLocal areaFlexible 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- ...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...Ongoing contractLocal areaWorldwideFlexible hours
- ...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
$90k - $105k
...THE GENEVA FOUNDATION is seeking a Regulatory Affairs Manager to oversee regulatory compliance for the MIRROR Program. The role involves managing a team, guiding submissions to institutional review boards, and ensuring adherence to regulatory standards for clinical research...Remote work$60 - $70 per hour
...Job Summary Randstad is seeking a highly organized Regulatory Compliance & Documentation Manager to lead a critical compliance and process‑optimization... ...completeness, and adherence to FRA standards prior to submission. Process Optimization: Analyze the current end‑to‑end...Hourly payContract workTemporary workWork experience placement- ...via Aqua-Swirl, Aqua-Filter, and Aqua-Ponic products. The Regulatory Manager will support the commercial growth of its stormwater... ...and approval Prepare, coordinate, and track regulatory submissions across municipalities, agencies, and certification programs...
$151k - $314k
...Overview The Head of US Regulatory Advertising & Promotion (... ...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 area3 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$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$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. 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- ...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
- ...& Medicaid Services (CMS). Provides expert interpretation of regulatory requirements affecting psychological practice, reimbursement,... ...priorities. Prepares formal comment letters and regulatory submissions on behalf of the Association to advance psychologists’...Temporary workWork at officeLocal areaRemote workFlexible hours
$220k - $230k
...Government Affairs Director, Spectrum Policy & Regulatory Affairs As a Government Affairs... ...reports and analysis Ensure senior management is fully briefed on major issues... ...ability with experience drafting items for submission to government authorities ~ Ability to...Work at officeRelocation$111.88k - $160.93k
...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 placementShift 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$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$100k - $117k
...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$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... .../Vets and maintains a drug‑free workplace. #J-18808-Ljbffr...Contract workWork at officeWork visa$82.5k - $209.5k
...Analytics is hiring for an AR Community product manager outbound role to help us gather product... ...our major Analyst reports and scorecard submissions. Translate that information into a... .../occupational health mandates, and/or drug testing requirements. Range and...Temporary workFlexible hours- ...Director and Assistant General Counsel with extensive experience in the airline industry and regulatory law. You will manage a portfolio of regulatory matters, draft submissions for rulemakings, and provide legal support across departments. The ideal candidate holds a...Work from home
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