Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 14 hours ago
Similar jobs that could be interesting for youBased on the Senior Global Regulatory Affairs: CMC/Devices Lead in Boston, MA vacancy
  • 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... 
    Senior
    Night shift

    Scorpion Therapeutics

    Boston, MA
    4 days ago
  • $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... 
    Senior
    Full time
    Temporary work
    Local area
    Worldwide
    Night shift

    JobRx, Inc.

    Boston, MA
    4 days ago
  • 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

    Alnylam Pharmaceuticals

    Cambridge, MA
    2 days ago
  •  ...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

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago
  • 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

    Barrington James

    Boston, MA
    2 days ago
  • 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... 

    SoTalent

    Boston, MA
    2 days ago
  • $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

    Katalyst CRO

    Boston, MA
    2 days ago
  • 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... 
    Senior
    Remote job

    Barrington James

    Boston, MA
    3 days ago
  • $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

    Caris Life Sciences

    Boston, MA
    2 days ago
  • 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... 
    Senior
    Full time
    Local area

    Takeda

    Cambridge, MA
    2 days ago
  • $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... 
    Senior
    Minimum wage
    Temporary work
    Local area

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago
  • $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;... 
    Senior
    Minimum wage
    Full time
    Temporary work
    Local area
    Worldwide

    Takeda

    Boston, MA
    2 days ago
  • 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... 

    Discover International

    Boston, MA
    4 days ago
  • $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,... 

    Solid Biosciences

    Boston, MA
    2 days ago
  • $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... 

    JobRx, Inc.

    Boston, MA
    3 days ago
  • 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

    Sanofi

    Cambridge, MA
    2 days ago
  • 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... 
    Senior
    Remote job

    Travere Therapeutics

    Boston, MA
    2 days ago
  • 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... 
    Senior
    Remote job

    Hmixray

    Somerville, MA
    3 days ago
  • $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

    Boston, MA
    2 days ago
  • 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

    JobRx, Inc.

    Boston, MA
    2 days ago
  • 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

    SoTalent

    Boston, MA
    2 days ago
  • 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

    Barrington James

    Boston, MA
    2 days ago
  • 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... 
    Senior
    3 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  • $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... 
    Senior
    Flexible hours

    MongoDB

    Boston, MA
    2 days ago
  •  ...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... 

    Takeda

    Boston, MA
    2 days ago
  • $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... 
    Senior
    Summer work
    Remote work
    Worldwide
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • 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... 

    Hydrogen Group

    Boston, MA
    2 days ago
  •  ...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... 
    Senior
    Work at office
    Local area
    Remote work
    Worldwide

    GlaxoSmithKline

    Cambridge, MA
    2 days ago
  •  ...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

    GlaxoSmithKline

    Cambridge, MA
    1 day ago
  • $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... 

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Global Regulatory Affairs: CMC/Devices Lead. Be the first to apply!