Remote Associate Director, Regulatory Affairs (ANDA/NDA)
Padagis
- Remote job
Padagis US LLC is seeking a Director or Associate Director of Regulatory Affairs to lead regulatory strategy and submissions for U.S. generic products, including ANDAs, INDs and NDAs, coordinating cross-functional teams and FDA communications. The role focuses on ensuring regulatory compliance, timely filings, and risk mitigation across development stages, with remote eligibility for U.S. residents. #J-18808-Ljbffr Padagis
- Padagis US LLC seeks an experienced Director or Associate Director of Regulatory Affairs to oversee regulatory strategies, submissions and writing for US generic products (ANDA/IND/NDA). The role is remote eligible for US residents, with preference for candidates in the...Remote job
$135.3k - $202.9k
...advancement across the globe.Scope: The Associate Director, Global Regulatory Affairs Lead is responsible for the... ...interactions with FDA or EMA including NDA / BLA activities.Demonstrated... ...with Monday and Friday offered as remote flexible.Pay Range for this position...Remote workLocal areaMonday to FridayFlexible hours$154.4k - $242.55k
...the delivery of global regulatory strategies to support... ...the Global Regulatory Affairs (GRA) function in senior... ...and supporting trade association working groups.... ...CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions... ...communicationLocation: Remote within the USTakeda Compensation...Remote workMinimum wageLocal area$154.4k - $242.55k
...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls... ...preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical... ..."hybrid" following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1Takeda...Remote workMinimum wageLocal areaWorldwide$164k - $213k
...Associate Director, Regulatory Affairs CMC At Insmed, every moment and every patient counts — and so does every... ...the CMC sections for IND/IMPD, NDA/MAA, and other regulatory submissions... ...Where You'll Work This is a fully remote role. It can be performed effectively...Remote workTemporary workFlexible hours- ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime type:... ...regulatory agencies for IND, IMPD, CTA, BLA, NDA, MAA.* Exceptional ability to... ...a dynamic workplace that balances remote work flexibility with the benefits of...Remote workContract work
- General Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting Date: Tuesday, July... ...-08-2026 Work Schedule: Full time Remote Work: In office Job: RI - R&D,... ...regulatory submissions, including IND/CTA, NDA/MAA, DMF/ASMF, briefing documents,...Remote workPermanent employmentFull timeTemporary workWork at office
$185k - $210k
...Associate Director, Regulatory Affairs The Associate Director, Regulatory Affairs, is responsible for leading one or more drug development programs... ...Environment This job operates in a professional or remote office environment and requires operating standard office...Remote workWork at office$164k - $225.5k
...our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. The Associate Director Regulatory Affairs is a key member of the global regulatory team. This role serves as a close business partner and facilitator of...Remote workTemporary workWork at office$103.6k - $288.6k
...Job Title Job Overview Line Management responsibilities for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites. Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs...Remote workFull timePart timeWork at officeImmediate startWorldwideFlexible hours- ...Executing regulatory oversight for advertising, promotion, and labeling, the full-time Associate Director, Regulatory Affairs will develop and implement regulatory strategies for product... ...FDA, EMA, and global regulations in a remote setting. Key responsibilities Serve...Remote workFull time
- ...Associate Director, Cmc Regulatory Affairs Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis... ..., money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships...Remote work
$145.6k - $279.4k
...work up to 50% of their monthly workday remotely. This role will not have the ability to... ...preparation, review, and submission of regulatory applications, including product registrations... ...devices. Represents Regulatory Affairs on research, development, and marketing...Remote workWork at officeRelocation packageFlexible hours- Praxis Precision Medicines, Inc. seeks an Associate Director of Regulatory Affairs (Advertising & Promotion) to lead the regulatory review of promotional materials across channels. This role will partner with Commercial, Medical Affairs, Legal, and Regulatory Strategy...Remote job
- Role: Associate Director, CMC Regulatory Affairs, providing strategic and operational leadership for regulatory activities related to small molecule drug... ...with major international regulatory agencies. Work Setup remote with some travel (~10%), onsite presence required in...Remote work
$180k - $241k
The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities... ...reports to the VP, Regulatory Affairs and is based remote. Regulatory Strategy Support: Support the development and...Remote workRelocation package$180k - $241k
...2000 employees. Job Description Primary Function: The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory... ...reports to the VP, Regulatory Affairs and is based remote. Major Responsibilities and Duties: Regulatory Strategy...Remote workWorldwideRelocation package$180k - $205k
...The Associate Director, Advertising, Promotion and Labeling will execute regulatory oversight for advertising, promotion, medical communications... ...and Labeling Location: Remote (West Coast hours preferred)... ...with Commercial, Medical Affairs, Legal, and Compliance to enable...Remote workFull timeWork at officeLocal area$164k - $225.5k
...argenx seeks an Associate Director of Regulatory Affairs to lead US regulatory strategy for its pipeline of autoimmune... ...across the product lifecycle in a remote position. Responsibilities... ...and critical review of IND, BLA, and NDA dossier content Ensure timely FDA...Remote work$177.4k - $238.96k
...investigational gamma secretase inhibitor for which an NDA has been accepted by the U.S. FDA; IM-1021, a clinical... ...tumor targets.Position OverviewImmunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global...Flexible hours- ...US LLC is seeking an experienced Director or Associate Director of Regulatory Affairs to lead regulatory strategies and... ...U.S. marketed products, primarily ANDAs for generic dosage forms. The role... ...readiness and timely approvals. This remote position favors candidates in the...Remote job
$180k - $205k
...Associate Director, Regulatory Affairs Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric... ...Global Submission & Portfolio Strategy; Contribute to NDA/MAA submission roadmaps, ensuring late-phase clinical,...Work at office$141.5k - $268.5k
Associate Director, Regulatory Affairs Advertising & Promotion - Oncology Full-time Salary Min: 141500 Salary Max: 268500 Workday Global Grade: 2... ...work a hybrid work schedule (3 days in office, 2 days remotely) from our Mettawa, IL;South San Francisco, CA;Florham Park...Remote workFull timeWork at office$166.4k - $249.6k
...Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for... ...Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical... ...designated as: 1. Hybrid : work remotely up to two days per week; or select...Remote workFull timeSummer workFlexible hours2 days per week- ...strategic, tactical and operational regulatory CMC leadership to support clinical trial... ...activities. Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for leading... ...lifecycle Experience with INDs, and NDA’s/BLAs Strong knowledge of GMP and...
$211k - $250k
...sunlight and liver damage. Who You Are A regulatory affairs leader who owns global regulatory... ...the program team. Prior ownership of an NDA or BLA is essential. Requirements... ...biotech or pharmaceutical industry for Associate Director; 8 years for Director, including experience...Flexible hours- ...implementing, and advising on regulatory strategies for development... ...company and industry are met. The Associate Director will also manage regulatory... ...Review sections of IND/CTA, NDA/MAA, and other global... ...Project Lead in Regulatory Affairs, leading multiple FDA interactions...
$161.6k - $242.4k
Job DescriptionGeneral Summary:The Regulatory Labeling Associate Director will be responsible for strategic labeling... ...8 years of experience in regulatory affairs in the area of global labeling or... ...) and so much more.Flex Designation:Remote-EligibleFlex Eligibility Status:In...Remote workFull timeSummer workWork at officeFlexible hours2 days per week$110k - $150k
...Business• Awareness and understanding of the trading businessesProcesses• Coordinate and manage regulatory examinations and regulatory visits/meetings.• With Regulatory Affairs team, act as main point of contact to regulators and ensure all requests are handled in timely...Work at officeLocal areaWork from homeFlexible hours$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic...Full timeTemporary workWork at officeLocal areaFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Remote Associate Director, Regulatory Affairs (ANDA/NDA). Be the first to apply!
- customer service rep remote Hendersonville, TN
- remote medical billing part time Hendersonville, TN
- remote legal Hendersonville, TN
- remote customer support Hendersonville, TN
- remote web developer part time Hendersonville, TN
- customer service representative (remote from home) Hendersonville, TN
- companies hiring remote Hendersonville, TN
- remote admin Hendersonville, TN
- medicare sales agent remote Hendersonville, TN
- implementation project manager remote Hendersonville, TN


