Senior Global Regulatory Affairs: CMC/Devices Lead
Katalyst CRO
Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory affairs, candidates should have 6+ years of relevant experience and a BS/BA in a scientific discipline. Strong analytical and communication skills are essential for this role. #J-18808-Ljbffr Katalyst CRO
- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination products with a... ...management. Maintain and communicate CMC/quality guidance and... ...foundational subject matter expert for global Human Factors regulation for...SeniorNight shift
$212k - $333.19k
...therapies to patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you... ...driving prospective and proactive implementation. Globally influences and serves as a key opinion leader and...SeniorFull timeTemporary workLocal areaWorldwideNight shift- Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this hybrid position, you will be responsible for implementing the global regulatory CMC strategy, shaping regulatory strategies for innovative modalities like oligonucleotide...Senior
- ...Therapeutics, Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle...Senior
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Suggested
- 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...
$193k - $210k
A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout... ...alignment with clinical plans and incorporating global Health Authority feedback. This role offers a competitive...Senior- A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission planning, ensuring compliance with regulatory authorities, and managing multiple priorities. Candidates...SeniorRemote job
$124k - $152k
Caris Life Sciences is seeking a Manager - Regulatory Affairs in Boston, MA. The role involves leading regulatory strategies for in vitro diagnostic projects. This... ...of regulatory submission experience in medical devices or IVDs. The position involves collaboration with...Senior- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring that... ..., enhancing their skills and knowledge in regulatory affairs Strong strategic planner with a proven ability to...SeniorFull timeLocal area
$212k - $333.19k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program... .... Accountabilities: The Senior Director will be responsible for... ...broad concepts within regulatory affairs and implications across the organization...SeniorMinimum wageTemporary workLocal area$208.2k - $327.14k
...lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global... ...such as understanding broad concepts within regulatory affairs and implications across the organization and globally;...SeniorMinimum wageFull timeTemporary workLocal areaWorldwide- Discover International is seeking a Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves supporting regulatory... ...navigate complex regulatory frameworks. You will lead global regulatory submissions and collaborate...
$170k - $220k
...medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication skills,...$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 in Morristown, NJ is looking for a GRA Device Associate - Medical Devices and Combination Products (Senior Manager) to drive regulatory strategies for innovative medical devices. You will partner with various teams, ensure compliance, and navigate complex regulatory...Senior
- Travere Therapeutics is looking for a Senior Manager in CMC Regulatory Affairs to provide strategic regulatory leadership in supporting biologics. This role involves developing global CMC regulatory strategies, managing submissions, and working closely with cross-functional...SeniorRemote job
- A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance...SeniorRemote job
$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory strategy and engaging with cross-functional teams to ensure the success of innovative oncology therapies. The successful candidate...Senior- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role involves leading global regulatory strategy for complex oncology projects, with responsibilities that include overseeing FDA submissions and ensuring compliance with regulatory...Senior
- Senior Manager, Global Regulatory Affairs (CMC) | Regulatory Strategy | CMC Submissions | Pharmaceutical R&D Role Overview... ...Regulatory Strategy & Submissions Lead execution of global CMC regulatory... ...regulatory affairs (CMC or device focus) Experience with IND, IMPD,...Senior
- Regulatory Affairs CMC, Manager/Senior Manager Currently partnering with a public Biotech who... ...Manager to support the global development and registration... .... Key Responsibilities Lead the preparation, coordination... ...products or drug-device programs is an advantage....Senior
- Vertex Pharmaceuticals is seeking a Regulatory Strategy Senior Director to lead regulatory approaches for various projects. The role, located in Boston,... ...candidate will possess significant expertise in regulatory affairs, strategic thinking, and excellent communication...Senior3 days per week
$151k - $297k
MongoDB is seeking a Senior Director for HR to partner with leadership and drive complex global change. This role involves shaping people strategy, driving revenue growth, and building leadership capability. Ideal candidates will have over 12 years in HR, including experience...SeniorFlexible hours- ...Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development of innovative regulatory strategies for device and drug-device combinations. This position... ...strategies, interfacing with global health authorities, and ensuring...
$240k - $360k
...autoimmune disease of the kidney that can lead to end-stage-renal disease. IgAN is... ...gravis (gMG).Vertex is seeking a Senior Director of Global Value & Access Strategy (GVAS) for povetacicept... ...HEOR, Real World Evidence, Government Affairs and Public Policy and to ensure...SeniorSummer workRemote workWorldwideFlexible hours2 days per week- A global healthcare firm is seeking a Regulatory CMC Lead in Boston, MA. The role requires expertise in regulatory strategy, operations, and planning for CMC aspects of assigned projects. Candidates should possess strong communication skills and a minimum of 3-5 years in...
- ...Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for... ...pharmaceutical, biologic, device or combination product... ...ability to influence the global internal/external regulatory... ...in global regulatory affairs, including communication...SeniorWork at officeLocal areaRemote workWorldwide
- ...thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for... ...compliance with FDA expectations and global standards. Prepare and review... ...of experience in CMC regulatory affairs mainly in the U.S., with a focus...Local area
$238k - $374k
Initial Therapeutics, Inc. is looking for an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and drug-device combination products. The successful candidate will have...
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