Global Regulatory Strategy Leader
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated is looking for a Regulatory Strategy Director based in Boston. This role will lead the development and implementation of regulatory strategies for various projects, ensuring compliance and effective communication across teams. The ideal candidate has a Bachelor's degree in a related field and over ten years of experience in regulatory affairs within the pharmaceutical industry. This position is hybrid-eligible, offering flexibility with on-site work. #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated
$260k - $360k
Rhythm Pharmaceuticals Inc. is seeking a Vice President of Regulatory Affairs to lead its Global Regulatory Affairs organization from Boston,... ...involves managing diverse teams, executing regulatory strategies, and ensuring high-quality outcomes in a fast-paced environment...Regulatory- Sanofi is seeking a Global Regulatory Lead to shape and execute innovative regulatory strategies for oncology products. This role interfaces with various teams to ensure compliance and strategic alignment, reporting directly to senior management. The ideal candidate will...Regulatory
- ...Therapeutics, Inc. in Watertown, Massachusetts is seeking a Vice President or Senior Vice President of Regulatory Affairs. This role leads global regulatory strategies for the oncology pipeline and ensures compliance with regulatory requirements. The ideal candidate...Regulatory
- ...Pharmaceuticals Incorporated is seeking a Regulatory Strategy Senior Director in Boston, a hybrid role where you will oversee the development of global regulatory strategies for various programs. The position requires a leader with at least 12 years of experience in regulatory...Regulatory
- Alnylam Pharmaceuticals is seeking an Executive Director for Global Trial Strategy & Operations in Cambridge, MA. This role involves strategic... ..., CNS, or Hematology. A strong understanding of regulatory compliance is essential. #J-18808-Ljbffr Alnylam PharmaceuticalsRegulatory
$210.4k - $331.1k
Merck is looking for a Principal Scientist in Global Regulatory Affairs for Vaccines and Infectious Disease. The role includes developing global regulatory strategies, leading cross-functional teams, and representing the company with regulatory agencies like the FDA. Candidates...RegulatoryFlexible hours- ...Endoluminal Robotics portfolio. The senior strategic architect will unify global digital and robotic surgery strategy, drive commercialization, and lead cross-functional teams across R&D, regulatory, and clinical functions. The role emphasizes coordinating with...Regulatory
- Verastem Oncology is looking for a Senior Director of Regulatory Affairs based in Boston, MA. This role involves leading the development and implementation of the global regulatory strategy for investigational products, ensuring alignment with U.S. regulations and international...Regulatory
- Sanofi is seeking a Global Project Head, GI Oncology Leader to drive disease-area strategy across assets and guide late-stage development with data-driven decision-making... ...and coordinate with external investigators and regulatory authorities to shape the GI #J-18808-Ljbffr...RegulatoryFlexible hours
- SoTalent seeks a Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and submissions for clinical development and post-approval. The role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment with global requirements...Regulatory
- A global pharmaceutical company seeks a Regulatory Affairs Specialist in Boston, MA. The role involves developing regulatory strategies for prescription drug submissions and managing lifecycle activities. Candidates should have a Bachelor's with 5+ years in regulatory affairs...Regulatory
- Mass Digital Health is seeking a Global Regulatory Lead to develop and execute innovative regulatory strategies across its product portfolio. Based in either Morristown, NJ, or Cambridge, MA, this role is vital to ensure compliance with industry standards while advocating...Regulatory
- Vertex Pharmaceuticals in Boston is seeking a Regulatory Strategy Associate Director responsible for overseeing global and regional regulatory strategies for development programs. The ideal candidate will have a comprehensive understanding of regulatory affairs, drug development...Regulatory
$193k - $210k
...pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle.... ...alignment with clinical plans and incorporating global Health Authority feedback. This role offers...Regulatory$209.35k - $258.6k
Akebia Therapeutics is seeking a Director of Regulatory Labeling in Cambridge, MA. This key role involves leading global labeling strategies across product life cycles and ensuring compliance with regulatory standards. The ideal candidate will have 10+ years of pharmaceutical...Regulatory- ...Inc (US) is seeking an Associate Director for Global Submission Management to oversee strategic global regulatory submissions across development and lifecycle programs... ...submissions aligned with global regulatory strategies. The role leads cross‑functional teams, manages...Regulatory
- AbbVie is seeking a Director Regulatory Affairs Global Regulatory Lead (GRL II) in Cambridge, MA. This role entails developing and implementing global strategies for product approvals while leading the Global Regulatory Product Team (GRPT). The ideal candidate will possess...Regulatory
$160k - $240k
Rhythm Pharmaceuticals Inc. is seeking a Global Regulatory Lead in Boston, Massachusetts. This position involves developing regulatory strategies, leading filings, and communicating with health authorities. The ideal candidate will have over 8 years of regulatory experience...Regulatory- A leading biotechnology firm in Boston is seeking a Regulatory Strategy Manager to oversee global regulatory activities for investigational products. This role includes preparing regulatory submissions, guiding the team on responses, and supporting NDA submissions. Ideal...Regulatory
- Beeline Medicines in Boston is seeking a Director of Regulatory Strategy to lead the global regulatory strategies for early-stage and pipeline programs in the immune and inflammation (I&I) therapeutic area. The role requires at least 10 years of regulatory experience,...Regulatory
$177k - $278.08k
Takeda is seeking a Director, Global Regulatory Lead Oncology to oversee regulatory activities for oncology programs in Boston, MA. This role... ...managing FDA submissions and setting global regulatory strategies. Ideal candidates will have 8+ years of pharmaceutical experience...Regulatory- Meet Life Sciences is seeking a Director / Senior Director, Global Regulatory Lead in Boston, MA to drive regulatory strategy across oncology programs. The ideal candidate will lead NDA submissions and collaborate with various teams, leveraging over 10 years of regulatory...RegulatoryWork at officeRelocation package
- Allergan is seeking a Director of Regulatory Affairs to develop and implement global regulatory strategies to secure product approvals. The role involves leading the Global Regulatory Product Team and requires strong leadership experience within the pharmaceutical sector...Regulatory
- Job Description OBJECTIVES/PURPOSE Lead development and advancement of Global Patient Access (GPA) strategies across programs, ensuring alignment with enterprise priorities, regulatory requirements, and product lifecycle needs Drive data‑driven and technology‑enabled...RegulatoryFull timeLocal areaNight shift
$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies for the company's early-stage and pipeline programs in the immunology and inflammation (I&I) therapeutic area, with...RegulatoryLocal areaFlexible hours2 days per week$100k - $143k
Relaytherapeutics in Cambridge, Massachusetts is looking for a motivated regulatory professional to join their regulatory team. In this role, you will support the development and execution of regulatory strategies for a transformative pipeline, contributing to IND, CTA, NDA,...Regulatory- Medella Life is looking for a Director of Regulatory Affairs to spearhead regulatory strategy for rare disease programs in Cambridge, MA. This role involves leading regulatory submissions and acting as the primary interface with health authorities like the FDA. The ideal...Regulatory
- Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US. Applicants should have...Regulatory
$238k - $374k
JobRx, Inc. is seeking an Executive Director for Global Regulatory Affairs CMC Early Development based in Boston. The ideal candidate will... ...provide strategic leadership, overseeing global CMC regulatory strategies for small molecules and biologics through Phase 2, and...Regulatory- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience...Regulatory
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