Regulatory Affairs Manager - Global Submissions & Strategy
Relay Therapeutics
Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years of experience in drug development and regulatory submissions. Join a passionate team committed to transforming drug discovery through precision medicine. #J-18808-Ljbffr Relay Therapeutics
- ...seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution. This role involves developing CMC... ...complex pharmaceutical products and guiding major submissions. The ideal candidate will have over 10 years of...Suggested
- Parexel in Boston seeks a Regulatory Affairs Consultant/Senior... .... You will guide global clinical development through regulatory strategy, health authority engagement... ...through lifecycle management. The role emphasizes... ...authority interactions, submission planning, and...Suggested
- ...company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Suggested
$177k - $278.08k
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience... ...with a strong focus on leading major submissions and ensuring regulatory compliance. This position...Suggested- ...(US) in Boston is seeking a Regulatory Strategy Associate Director to oversee the development of global regulatory strategies for their... ...involves leading regulatory submissions and mentoring team members on... ...of experience in regulatory affairs. The position offers a competitive...Suggested
$196.7k - $353.4k
...to lead development and execution of global regulatory strategy for programs in its oncology... ...commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence... ...Demonstrated competence in employee management and development Knowledge of and broad...Permanent employment$196.7k - $353.4k
...biotechnology firm in Cambridge, Massachusetts, is seeking a seasoned regulatory leader to drive global regulatory strategy for their oncology portfolio. Responsibilities include leading regulatory submissions, health authority interactions, and developing high-performing...- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses... ...setting the global regulatory strategy and overseeing all regulatory activities... ...teams to ensure timely and quality submissions to the FDA and other agencies. Ideal candidates...
- ...strategic Director of Regulatory Affairs to lead and support global regulatory efforts across... ...executing regulatory strategies that support global product... ...approval and lifecycle management. Ensure regulatory... ...Lead the preparation, submission, and maintenance of regulatory...
- ...Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for... ...understanding of regulatory affairs frameworks and a minimum of 8 years... ..., and ensuring compliance of submissions. Vertex offers a hybrid work...
$211.5k - $258.5k
BioSpace is seeking a Director, Regulatory Strategy to manage global regulatory strategies for early-stage programs in immunology and inflammation. This hybrid role requires expertise in FDA and EMA submission processes and leading regulatory interactions. Qualifications...- ...is looking for a Director to define and lead global regulatory strategies in Boston, MA. The ideal candidate will manage the Global Regulatory Teams, ensure compliance... ...regulatory requirements, and oversee all FDA submissions. The role demands strong leadership,...
$245k - $300k
...Biosciences in Cambridge, MA is seeking a Sr. Director, Regulatory Affairs to lead and execute global regulatory strategies. The ideal candidate will oversee health authority interactions, regulatory submissions, and strategic guidance for innovative therapeutics. Key...$177k - $278.08k
...Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible... ...How you will contribute Management of Labeling Cross‑... ...Labeling Documents Authoring, Submission, and Labeling... ...clinical, safety, medical affairs, and commercial. Builds...Full timeTemporary workLocal areaWorldwide- ...Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic... ...and executing regulatory strategies to support global product development,... ...leadership skills, and the ability to manage regulatory submissions and work with health authorities...
- AstraZeneca GmbH in Boston, MA is seeking a Director of Regulatory Affairs Strategy for Cell Therapy to lead global regulatory strategy across oncology, immune-... .... You will drive Health Authority engagements, submissions, and labeling, mentor cross-functional teams, and...
- ...experienced Associate Director of Regulatory Strategy to lead oncology... ...extensive experience in regulatory affairs, particularly in oncology,... ...alignment between US and global strategies. Exceptional... ...interactions and regulatory submissions. The role offers robust healthcare...
- ...Associate Director of Regulatory Strategy to support programs... ...in the US and other global markets. Responsibilities... ..., including for IND submissions. Lead the strategy... ...additional data; organize and manage participation in... ...serve as regulatory affairs representative to...
$211.5k - $258.5k
...Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible... ...member of the Regulatory Affairs team, this individual also... ...pre‑IND planning, IND/CTA submission strategy, Phase I/II/III... ...meetings, including management of timelines, briefing document...Local areaFlexible hours2 days per week- ...Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle... .... You will partner with Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising &...
- ...Pharmaceuticals Inc is seeking a Director, Global Submission Management (GSM) to provide strategic oversight and execution of global regulatory submissions across development and... ...submissions aligned with global regulatory strategies. It requires leadership across...
- Senior Manager, Global Regulatory Affairs (CMC) | Regulatory Strategy | CMC Submissions | Pharmaceutical R&D Role Overview Senior regulatory role within global R&D (Chemistry, Manufacturing & Controls - CMC) Responsible for executing regulatory strategy across clinical...
- Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and lifecycle programs, aligning with regulatory strategies and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising...
- ...Job Title: Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy Responsible for developing and implementing global strategies to secure... ...with global regulatory requirements, and manages compounds through all phases of development,...
- ...biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic regulatory... ...programs, ensuring compliance, and overseeing global regulatory strategies. The ideal candidate will have over 15 years of experience...
$192.4k - $260.4k
Overview The Director, Head of Global Trade Compliance and Strategy is a key supply chain leader responsible... ...direction, drive proactive regulatory engagement, and partner with senior... ...technology enablement such as global trade management systems, and benchmarking...Full timeTemporary workLocal areaFlexible hours- Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing labeling content and strategy for multiple products in various stages of drug development. The role requires 10+ years of pharmaceutical...
$189k - $246k
..., located in Boston, is seeking a Director of Regulatory Affairs Strategy. The role involves developing and executing global regulatory strategies for Phase 2 and Phase 3... ...regulatory lead, you will ensure compliance, manage interactions with global health authorities, and...Remote job$210k - $235k
Vor Bio is looking for a Director of Regulatory Strategy in Boston, MA. This role involves global leadership in regulatory strategy for developmental programs in... ...authorities. A Bachelor's degree and 7+ years in Regulatory Affairs is required. Offering competitive salary ($210-235...Remote jobFlexible hours- A global pharmaceutical company is seeking a Director of Regulatory Affairs to lead the development and implementation of global regulatory strategies for products in Boston. The ideal candidate will have... ...role with proven project management skills. This position also...
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