Global Regulatory Affairs Ops Leader - Compliance & Process
$208.2k - $327.14kBioSpace
A leading biotech company in Boston seeks a Head of Global Regulatory Affairs Operations. This senior role focuses on overseeing global regulatory submissions and ensuring compliance across the PDT organization. The ideal candidate will have 7-10 years of experience in regulatory affairs within the pharmaceutical industry and excellent leadership skills. The position offers a hybrid work model and a competitive salary range of $208,200 - $327,140. #J-18808-Ljbffr BioSpace
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- Discover International is seeking a Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves supporting regulatory strategy and execution for innovative biologic therapies. The ideal candidate will have extensive experience...Suggested
$260k - $360k
Rhythm Pharmaceuticals Inc. is seeking a Vice President of Regulatory Affairs to lead its Global Regulatory Affairs organization from Boston, Massachusetts. This senior role involves managing diverse teams, executing regulatory strategies, and ensuring high-quality outcomes...Suggested- Takeda in Boston, MA seeks a Head of Ethics & Compliance for GSQ and PDT to lead strategic ethics programs across product development,... ...sourcing and plasma operations. The role partners with senior leaders to embed integrity, risk management and governance, while driving...
$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 working...- Sanofi is seeking a Global Project Head, Toxicology in Cambridge, MA to lead the preclinical safety portfolio. You will guide a team... ..., shape strategy, and partner across Clinical Development, Regulatory Affairs, and DMPK to ensure high-quality submissions. The role...
- ...Manager is a senior leader at the... ...Iterative Health's global research network —... ...repository management, and process standardization. Coordinate... ...support contract compliance and operational... ..., and applicable regulatory standards.... ...Secretary of Veterans Affairs; or a person who was...Contract workTemporary workFor contractorsFor subcontractorH1bWork at officeLocal areaWork visa2 days per week
$212k - $333.19k
...develops and leads global strategies to maximize global regulatory success towards... ...programs, while ensuring compliance with applicable... .... Is a leader both in the department... ...drug development process and regulatory requirements... ...within regulatory affairs and implications...Minimum wageTemporary workLocal area$212k - $333.19k
...worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part... ...working knowledge of drug development process and regulatory requirements. Knowledge... ...broad concepts within regulatory affairs and implications across the organization...Minimum wageTemporary workLocal areaWorldwide- ...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 should possess an advanced...
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role... .... This role helps ensure compliance with legislation and regulations... ...compliance strategies and processes Prepare, review, and... ...and knowledge in regulatory affairs Strong strategic planner with...Full timeLocal area
- Skedda is seeking a Manager, People Operations + Employee Experience to drive all people processes for 110+ teammates worldwide in a hybrid Boston role. You’ll report to the VP, People and Operations and be in the Boston office near Downtown Crossing 4-5 days per week....Work at officeWorldwide
- Alexion Pharma Spain S.L. in Boston, MA, seeks a Chief of Staff, Senior Director Global Regulatory Affairs to partner with the VP and drive strategy-to-execution across Global Regulatory Affairs. The role ensures governance, prioritization, and enterprise coordination to...
- ...operations in a fast-paced environment. You will work closely with the TA Unit Head and external partners, handling confidential information with discretion and professionalism while facilitating cross-functional collaboration across global teams. #J-18808-Ljbffr Sanofi
$211.5k - $258.5k
...Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible... ...member of the Regulatory Affairs team, this individual also... ...which you are hired, in compliance with local laws and... ...application or interview process, please contact ****@*****.***...Local areaFlexible hours2 days per week$148.5k - $214.5k
...Job title CMC dossier leader Location : Framingham,... ...department within Sanofi R&D Global CMC Development... ...preparation of CMC dossiers for regulatory submissions to enable... ...and development processes. Drive alignment... ...development and/or regulatory affairs. AI applications and...- ...Associate Director, Supply Chain to lead the design and execution of a global clinical supply chain for specialized therapies. This key role is responsible for overseeing the clinical supply chain process, ensuring seamless delivery of investigational medicinal products (...
- Axon is searching for a Direct Tax Manager based in Boston, Massachusetts. This role is pivotal for supporting the global direct tax function and involves working closely with various departments to ensure accurate and timely tax operations. The successful candidate will...
- A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should...Remote work
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Job title: Global Regulatory Lead Location: Morristown, NJ / Cambridge, MA About the job As the Global Regulatory Lead on our Global Regulatory Affairs, Oncology Team, you’ll be fully accountable decision maker for the development & execution of creative, thoughtful,...- 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...
- ....com is seeking a Vice President, Brand & Creative to lead its global brand strategy and creative organization from Boston, Scottsdale... ...with data‑driven decision making, embraces AI in the creative process, and partners across functions to deliver campaigns, customer stories...
$192.4k - $260.4k
Alnylam Pharmaceuticals is seeking a Director, Head of Global Trade Compliance and Strategy in Cambridge, MA. This role is responsible for designing and overseeing the global trade compliance program and will lead a team of trade compliance professionals. Candidates should...- ...Holdings B.V is looking for a Vice President, Global Mobility Program Technology. This senior... ...across various platforms while ensuring compliance and scalability. The position requires... ...proven track record in global mobility processes. This position is essential for enabling...
$95k - $105k
L.E.K. Consulting seeks a Global IT Finance & Procurement Manager based in Boston. This role leads the firm's procurement, vendor management... ...leadership skills, and a strong understanding of procurement processes. A competitive salary of $95,000-$105,000 and comprehensive...- Rhythm Pharmaceuticals, Inc is seeking a Head of Global Strategic Sourcing to lead the organization’s sourcing function. This role is... ...operational, and business goals. You will oversee strategic sourcing processes, risk management, and supplier relations. Ideal candidates have...
- 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...
$216k - $324k
...Respiratory & Immunology (R&I) as a Global Product Leader (GPL) for an asset in... ...perspectives into the process. As the lead ambassador for... ...on safety and efficacy for regulatory approval plus value for market... ...appropriate Governance and Compliance and protects AZ’s Rights,...Temporary workWork at officeFlexible hours3 days per week
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