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

Global Regulatory CMC Lead: Submissions & Strategy (Hybrid)

Takeda Pharmaceuticals

Takeda in Boston is seeking an experienced professional to lead Regulatory CMC strategies and manage regulatory submissions. The candidate should have over 6 years of experience in pharmaceutical regulatory affairs and a strong foundation in CMC regulations. This role plays a critical part in ensuring product success and compliance with regulatory requirements. This position offers a hybrid working arrangement and competitive benefits including salary and health insurance options. #J-18808-Ljbffr Takeda

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory CMC Lead: Submissions & Strategy (Hybrid) in Boston, MA vacancy
  • $177k - $278.08k

    JobRx, Inc. is seeking a Regulatory Affairs professional in Boston...  ..., MA to manage regulatory CMC strategy for pharmaceutical...  ...experience with a strong focus on leading major submissions and ensuring regulatory...  ...compliance. This position offers a hybrid work model and a... 
    Regulatory

    JobRx, Inc.

    Boston, MA
    3 days ago
  • Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and post-approval processes...  ...of CMC regulations. This position offers a hybrid work model along with competitive compensation... 
    Regulatory

    Takeda

    Boston, MA
    2 days ago
  • A leading biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves managing post-approval...  ..., ensuring compliance with global regulations, and leading...  ...while driving innovative regulatory strategies. #J-18808-Ljbffr Takeda
    Regulatory

    Takeda

    Boston, MA
    4 days ago
  • $137k - $215.27k

     ...professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory...  ...Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a salary range of $137,000... 
    Regulatory

    Initial Therapeutics, Inc.

    Boston, MA
    3 days ago
  • $153.6k - $241.34k

    A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and offers...  ...in Boston, MA, the position is hybrid and provides a competitive salary range... 
    Regulatory

    Takeda

    Boston, MA
    5 days ago
  • $113.85k - $189.75k

     ...Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for...  ...FDA expectations and global standards. Prepare...  ...focus on IND and BLA submissions to the FDA. Experience...  ...model This role is hybrid. You will be expected... 
    Regulatory
    Full time
    Local area

    GSK

    Cambridge, MA
    3 days ago
  • Scorpion Therapeutics in Cambridge, Massachusetts is seeking a leader in Global Regulatory Affairs CMC to oversee regulatory strategy and submissions for small molecules and biologics. The ideal candidate should have over 20 years of experience in the industry and a strong... 
    Regulatory

    Scorpion Therapeutics

    Cambridge, MA
    4 days ago
  • $238k - $374k

     ...Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and...  ...track record in managing submissions and aligning cross-...  ...The position offers a hybrid work model, competitive... 
    Regulatory

    Initial Therapeutics, Inc.

    Boston, MA
    1 day ago
  • Sanofi is seeking a Global Submission Lead to manage regulatory submission activities for new global products. The role involves project management, ensuring compliance with regulatory standards, and leading cross-functional teams in a dynamic environment. The ideal candidate... 
    Regulatory

    Sanofi

    Cambridge, MA
    5 days ago
  • 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... 
    Regulatory

    Katalyst CRO

    Boston, MA
    2 days ago
  • Moderna Therapeutics in Norwood, MA is seeking a Regulatory CMC Lead to manage a team of CMC experts. This role involves overseeing regulatory strategies for a portfolio of products, ensuring compliance with health authority guidelines, and leading interactions with regulators... 
    Regulatory

    Moderna Therapeutics

    Norwood, MA
    4 days ago
  • $270k - $330k

    Ipsen Biopharmaceuticals Inc. is looking for a Senior Director of Global Regulatory Affairs specializing in Oncology. This critical role demands extensive regulatory leadership to manage programs, ensuring compliance and strategic alignment with global development objectives... 
    Regulatory

    Ipsen Biopharmaceuticals Inc.

    Cambridge, MA
    1 day ago
  • $212k - $333.19k

     ...Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-...  ...product regulatory strategies particularly pertaining...  ...implementation. Globally influences and...  ...global regulatory submissions (e.g., Core Dossiers...  ...currently classified as hybrid following Takeda's... 
    Regulatory
    Minimum wage
    Temporary work
    Local area
    Remote work
    Worldwide
    Night shift

    Takeda Pharmaceutical

    Cambridge, MA
    5 days ago
  • Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the role As Global Submission...  ..., coordination, and tracking of regulatory Priority portfolio and Integration submission...  ...companies for e‑Submission strategies. Coordinate with Regulatory Operations... 
    Regulatory
    Worldwide

    Sanofi

    Cambridge, MA
    1 day ago
  • $122.25k - $176.58k

    Job title: Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the job As Global...  ..., coordination, and tracking of regulatory Priority portfolio and Integration submission...  ...for implementation of e‑Submission strategies between two companies. Ensure that... 
    Regulatory
    Worldwide
    Flexible hours

    Mass Digital Health

    Cambridge, MA
    2 days ago
  • $154.4k - $242.55k

     ...for the world. As a global, values‑based...  ...Global Risk Financing Strategy and ensuring...  ...group strategy. Lead specific Global Insurance...  ...of underwriting submissions and support any market...  ...challenges and/or regulatory issues; recommend...  ..., MA. This is a hybrid role with onsite... 
    Regulatory
    Minimum wage
    Full time
    Contract work
    Temporary work
    Work at office
    Local area
    Immediate start

    Takeda

    Cambridge, MA
    4 days ago
  • $177k - $278.08k

     ...This role is within the Global Regulatory Affairs (GRA)...  ...Manufacturing & Controls (CMC) and Devices organization...  ...the regulatory CMC strategy and leads the execution of...  ...global registrational submissions of complex drug product...  ...currently classified as hybrid following Takeda's... 
    Regulatory
    Minimum wage
    Temporary work
    Local area
    Immediate start
    Remote work
    Worldwide

    Takeda Pharmaceutical Company Ltd

    Cambridge, MA
    2 days ago
  • $177k - $278.08k

     ...This role is within the Global Regulatory Affairs (GRA)...  ...Manufacturing & Controls (CMC) and Devices organization...  ...the regulatory CMC strategy and leads the execution of...  ...global registrational submissions of complex drug product...  ...currently classified as "hybrid" following Takeda's... 
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda Pharmaceutical Company Ltd

    Boston, MA
    2 days ago
  • $137k - $215.27k

     ...role is within the Global Regulatory Affairs (GRA)...  ...Manufacturing & Controls (CMC) and Devices...  ...supervision, leads the execution of...  ...or post-approval strategies for assigned products...  ...and accurate submissions. Develops constructive...  ...classified as hybrid following Takeda'... 
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Takeda Pharmaceutical Company Ltd

    Boston, MA
    4 days ago
  •  ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at...  ...drugs, and a strong understanding of CMC requirements. Key responsibilities include managing... 
    Regulatory

    Monte Rosa Therapeutics

    Boston, MA
    3 days ago
  •  ...Rosa Therapeutics is seeking a Regulatory Operations Manager in Boston,...  ...with proficiency in eCTD submissions and vendor oversight. The candidate...  ..., maintain compliance with global standards, and prepare...  ...position offers an opportunity to lead cross-functional teams and contribute... 
    Regulatory

    Monte Rosa Therapeutics

    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... 
    Regulatory

    JobRx, Inc.

    Boston, MA
    5 days ago
  • $238k - $374k

     ...Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device...  ...robust regulatory strategies for medical devices...  ...you will contribute: Leads and develops a team...  ...strategy and major submissions for an assigned portfolio...  ...classified as hybrid following Takeda's Hybrid... 
    Regulatory
    Minimum wage
    Temporary work
    Work at office
    Local area
    Remote work
    Worldwide

    Takeda Pharmaceutical

    Cambridge, MA
    2 days ago
  •  ...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. Applicants must... 
    Regulatory

    Initial Therapeutics, Inc.

    Boston, MA
    1 day ago
  • $125k - $258k

    A leading compliance firm in Boston is seeking a Head of Global Sanctions to oversee the enterprise-wide sanctions program. This role requires a senior executive...  ...robust compliance while navigating complex regulatory landscapes. The position offers a competitive salary... 
    Regulatory

    Soteria Reinsurance Ltd.

    Boston, MA
    3 days ago
  •  ...and strategic Director of Regulatory Affairs to lead and support global regulatory efforts...  ...and executing regulatory strategies that support global product...  ...background is preferred. CMC experience is a plus....  .... Lead the preparation, submission, and maintenance of regulatory... 
    Regulatory

    Monte Rosa Therapeutics, Inc

    Boston, MA
    5 days ago
  •  ...Alfasigma is seeking a Manager, Regulatory Lead to support regulatory strategy development and IND submissions in a fast-paced environment based in Boston. This role involves collaboration and project management across various functions. Ideal candidates will have... 
    Regulatory
    Remote work

    Alfasigma USA

    Boston, MA
    1 day ago
  •  ...Cambridge, MA is seeking an Associate Director, Regulatory Affairs CMC to lead the development and execution of global regulatory strategies for innovative therapeutics, particularly...  ...leadership. The position allows for hybrid work arrangements, reflective of Alnylam's... 
    Regulatory

    Alnylam Switzerland GmbH

    Cambridge, MA
    1 day ago
  • $177k - $278.08k

     ...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of...  .... Accountable for all US FDA submissions and approvals of project(s) of responsibility...  ...is currently classified as “hybrid” in accordance with Takeda’s... 
    Regulatory
    Minimum wage
    Full time
    Temporary work
    Local area
    Remote work

    Takeda Pharmaceutical Company Ltd

    Boston, MA
    2 days ago
  • A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in...  ...candidate will prepare regulatory submissions, interact with health...  ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr... 
    Regulatory

    Noema Pharma AG

    Boston, MA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Regulatory CMC Lead: Submissions & Strategy (Hybrid). Be the first to apply!