Director, Regulatory Affairs
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Flagship Pioneering seeks a Regulatory Counsel to join its Legal team. The role leads regulatory efforts tied to government contracting obligations and advises on GxP, consumer/digital health, and medical device matters across the company portfolio.
Ideal candidates have a JD, active US bar, and 6–10 years of regulatory law experience, including global regulatory strategy and prior in-house or law-firm work. This is an in-person Cambridge, MA position with high visibility and impact.
#J-18808-Ljbffr$142.5k - $256.5k
...The Role The Associate Director, Global Regulatory Advertising and Promotion will be responsible for ensuring compliance with regulatory requirements... ...This role will serve as a key liaison between Regulatory Affairs, Legal, Medical, and Commercial teams to provide strategic...SuggestedPermanent employmentWork at officeWork from home$170.9k - $231.3k
## Associate Director, Regulatory Affairs, CMCUnited StatesApply NowFind out how well you match with this jobJob ID3315This role is considered:Hybrid**Overview**The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours- ...Cambridge, US; New Jersey, US | full time | Job ID: 9842 About the role: As an Associate Director in Regulatory Affairs, Advertising and Promotion at BioNTech, you will play a pivotal role in ensuring our promotional materials and medical communications comply with...SuggestedFull timeWork at office
$281k - $344k
...patients – realizing a world where people with immune‑mediated diseases can live life fully. Job Summary: The Executive Director, Regulatory Affairs will report to the Senior Vice President, Regulatory Affairs & Quality and serve as the Global Regulatory Lead to...SuggestedFor contractorsLocal areaFlexible hours2 days per week$163.5k - $281.6k
...that truly matters for patients, we invite you to join us. Responsibilities Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions. Lead and manage...SuggestedFull timeFor contractorsWork at officeFlexible hours- ...Jobtailor in Boston is seeking a Senior Regulatory CMC Leader to develop and implement global regulatory CMC strategies for gene therapy programs, lead submission activities, and act as the primary liaison with health authorities such as the FDA and EMA. You will guide...
- ...Role: Senior Director of Regulatory Strategy leading regulatory affairs and health authority interactions for gene therapies at Genetix Biotherapeutics. Responsibilities develop and execute global regulatory strategies, support FDA and EMA engagements, lead lifecycle...
- ...Medical Officer Position Summary This individual will lead regulatory strategy and execution for growing clinical-stage oncology... ...strategically, work independently, and help build Regulatory Affairs capabilities as the clinical pipeline grows. Key Responsibilities...2 days per week3 days per week
- ...Scorpion Therapeutics is seeking a Senior Director or VP of Regulatory Affairs to lead regulatory strategy, submissions, and agency interactions for oncology therapeutics. This role drives global regulatory plans and supports product development with a focus on achieving...
- ...Vertex Pharmaceuticals LLC is seeking a Director of Regulatory Affairs CMC in Boston. The role leads a Regulatory CMC team, shaping global strategies for small molecule programs and coordinating Health Authority interactions across development and commercialization....
$170k - $195k
...more information, visit or follow us on LinkedIn. What's the opportunity? We are seeking a highly skilled Associate Director, Regulatory Affairs to support and help drive regulatory success and shape the development of life-changing treatments. In this role, you...Work experience placementShift work- ...Job Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid or East Coast, USA) Employment Type: Full-time, Permanent About the Company Our client is a growing consultancy supporting innovative biotechnology and pharmaceutical...Permanent employmentFull time
$231.9k - $365k
...Job Description Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely,... ...professionalism. Position Description: The Executive Director, Regulatory Affairs Liaison reports to the Vice President (VP...Full timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$210k - $245k
...mRNA tolerizing therapies designed to selectively expand regulatory T cells and reset the immune system. Repertoire was founded... ...Repertoire Immune Medicines is seeking an experienced Director of Regulatory Affairs to serve as the company’s first internal Regulatory...Full timeTemporary workWork experience placementWork at officeFlexible hours3 days per week$200k - $240k
...the spectrum of antibody-driven diseases. The Associate Director, Regulatory Operations will play a key role in supporting global regulatory... ..., and lifecycle management, working closely with Regulatory Affairs leadership and cross-functional teams to ensure high-quality...Work at officeLocal area$90k - $200k
...management and enhancement of client relationships. Plan and manage a broad range of complex investigations, forensic accounting, regulatory compliance, including business intelligence, internal (client) investigations, insider risk compliance assessments, consulting...Temporary workFlexible hours$245k - $300k
...Job Description Job Description Description: Sr. Director, Regulatory Affairs At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke...Local area- ...provides high-quality and efficient services to the schools to help them achieve their goals. Job Description Reporting to the Director of the Office for Community Support, Non-Discrimination, Rights and Responsibilities (CSNDR) and University Title IX Coordinator,...Work at officeLocal area
- ...healthcare and corporate compliance program aligned with its growth. You will provide proactive guidance across commercial, medical, regulatory, and corporate activities. The role requires a JD with 5–7+ years in life sciences, plus experience in advertising,...
$220k - $370k
...Description Job Description Our Clinical Development team is seeking a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven track record of leading successful BLA submissions and desires to be part of...Summer workWork at officeFlexible hours- ...COMPLIANCE DIRECTOR Our client is currently seeking a Compliance Director who will... ...compliance program to ensure adherence to legal, regulatory, and internal policies. The Compliance... ..., risk management, or regulatory affairs, with a strong understanding of industry...Local area
$80k - $120k
Description The Role We are seeking an organized and detail-oriented Retirement Plan Compliance Analyst to join our team. As a compliance analyst you will play a crucial role in supporting our attorneys by performing a variety of tasks, which will include drafting...Temporary workWork at officeLocal areaVisa sponsorshipWork visaFlexible hours$250k - $310k
...Role Summary The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long‑term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne’s regulatory operations. The Executive...Local area$154.4k - $242.55k
...leads global strategies to maximize global regulatory success towards achievement of program... ....Accountabilities:The Associate Director will be responsible for complex or highly... ...understanding broad concepts within regulatory affairs and implications across the organization...Minimum wageTemporary workLocal areaRemote work$290k - $323k
...LinkedIn and X. Responsibilities Lead and/or oversee global regulatory CMC submissions (e.g., INDs, CTAs, BLAs, MAAs etc.) through... ..., Ph.D., etc.) required ~12 years’ experience in Regulatory Affairs CMC in Pharma/Biotech ~ Strong negotiation skills with...Contract workTemporary workFor contractorsFlexible hours$154.4k - $242.55k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...Minimum wageTemporary workLocal areaRemote workWorldwide$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per week- At KPMG, you can become an integral part of a dynamic team at one of the worlds top tax firms. Enjoy a collaborative, future-forward culture that empowers your success. Work with KPMGs extensive network of specialists; enjoy access to our Ignition Centers, where deep industry...Full timeLocal area
$95k - $165k
...Description As a Director - Compliance Consultant you will lead complex Health & Benefits compliance engagements while serving as... ...related advisory roles Deep knowledge of U.S. health and welfare regulatory requirements and regulatory interpretation Demonstrated...Temporary workLocal areaVisa sponsorshipWork visaFlexible hours$182k - $275k
...is responsible for executing high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and Technical Operations. This individual contributor role will execute...Work at office
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