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

Global Site CMC Director | Regulatory Change Lead

Initial Therapeutics, Inc.

Boston, MA

Takeda is seeking a Director Regulatory Site CMC in Boston, MA, to lead regulatory change management activities and ensure compliance with global HA requirements. The ideal candidate has over 10 years of biopharmaceutical/device industry experience and a strong understanding of regulatory strategy. This position promotes an agile approach in regulatory processes and encourages the use of automation to enhance efficiency. A hybrid work model is offered, complementing a robust compensation package and benefits for employees. #J-18808-Ljbffr Initial Therapeutics, Inc.

Apply
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Global Site CMC Director | Regulatory Change Lead in Boston, MA vacancy
  • Senior Director, Global Regulatory Affairs CMC
     ...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... 
    Suggested

    Initial Therapeutics, Inc.

    Boston, MA
    3 days ago
  • Executive Director, Global Regulatory Affairs CMC Early Development

    $238k - $374k

     ...of what is possible in order to bring life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide...  ...EU, Japan, China). How You Will Contribute Leads and develops a team of regulatory leaders... 
    Suggested
    Full time
    Temporary work
    Local area
    Worldwide

    JobRx, Inc.

    Boston, MA
    2 days ago
  • Director, Global Regulatory Affairs CMC
     ...possible in order to bring life‑changing therapies to patients...  ...Role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and...  ...the regulatory CMC strategy and leads the execution of regulatory CMC... 
    Suggested
    Full time
    Local area
    Worldwide

    Initial Therapeutics, Inc.

    Boston, MA
    1 day ago
  • Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product

    $238k - $374k

     ...of what is possible in order to bring life‑changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination...  ...Japan, China). How you will contribute Lead and develop a team of regulatory leaders and... 
    Suggested
    Minimum wage
    Full time
    Temporary work
    Work at office
    Local area
    Remote work
    Worldwide

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago
  • CMC Regulatory Affairs Manager, Global Submissions

    $139k - $172k

    Akebia Therapeutics is seeking a Manager for Regulatory Affairs CMC based in Cambridge, MA, transitioning to Waltham, MA. This role involves implementing global CMC strategies and ensuring compliance for submissions to FDA and EMA. Candidates should have at least 5 years... 
    Suggested

    Scorpion Therapeutics

    Cambridge, MA
    2 days ago
  • Associate Director, Global Regulatory CMC

    $142.5k - $256.5k

    The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC...  ...to health authority guidelines Lead Regulatory CMC discussions and interactions...  ...Perform assessment of manufacturing change controls Support development of... 
    Permanent employment
    Work at office
    Work from home

    Initial Therapeutics, Inc.

    Norwood, MA
    4 days ago
  • Director, Regulatory CMC

    $204k - $245k

     ...approach every challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC regulatory strategies for approved and late...  ...with a primary focus on lifecycle management, change management, and regulatory compliance. This... 
    Full time
    Work at office
    Flexible hours
    3 days per week

    Genetix Biotherapeutics

    Somerville, MA
    4 days ago
  • CMC Regulatory Director - Global Strategy & Submissions

    $177k - $278.08k

    JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position... 

    JobRx, Inc.

    Boston, MA
    20 hours ago
  • Director, Regulatory Affairs - Global Regulatory Strategy
     ...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs,...  ...is required, and immunology background is preferred. CMC experience is a plus. Responsibilities Develop and... 

    Monte Rosa Therapeutics, Inc

    Boston, MA
    1 day ago
  • Director, Regulatory Site CMC

    $177k - $278.08k

     ...possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and...  ...strong practical experience with global HA requirements, beyond EU/US....  ...teams. How you will contribute Lead site‑specific post‑approval change... 
    Minimum wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Initial Therapeutics, Inc.

    Boston, MA
    3 days ago
  • Director, Global Regulatory Submissions (Hybrid)
    Vertex Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development and lifecycle programs, aligning...  ...strategies and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising & Promotion... 

    Vertex Pharmaceuticals

    Boston, MA
    10 hours ago
  • Director Regulatory Site CMC (Hybrid) - Post-Approval

    $174.5k - $274.23k

    A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and post-approval activities, ensuring compliance across...  ...industry, with a strong background in global HA requirements and regulatory... 

    BioSpace

    Boston, MA
    4 days ago
  • Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human[...]
    Responsibilities Lead development and implementation of regulatory strategies for pure device and drug...  ...Maintain and communicate CMC/quality guidance and...  ...subject matter expert for global Human Factors regulation...  ...and compliance activities (change controls, deviations, investigations... 
    Night shift

    Scorpion Therapeutics

    Boston, MA
    3 days ago
  • Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human[...]

    $212k - $333.19k

     ...what is possible in order to bring life‑changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human...  ...and proactive implementation. Globally influence and serve as a key opinion leader... 
    Minimum wage
    Full time
    Temporary work
    Local area
    Worldwide
    Night shift

    Takeda

    Boston, MA
    3 days ago
  • Senior Director, Global Regulatory Strategy

    $211.85k - $317.78k

     ...Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location...  ...spirit and autonomy of a leading biotech. You’ll join an energising and...  ...Demonstrated ability to innovate, lead change, and solve critical regulatory science... 
    Hourly pay
    Temporary work
    Work at office
    3 days per week

    AstraZeneca

    Boston, MA
    2 days ago
  • Director, RA Global Regulatory Strategy

    $182k

     ...visit us at Follow @abbvie on LinkedIn, ( Facebook, Instagram ( , X ( and YouTube. ( Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to... 
    Local area
    Worldwide

    AbbVie

    Watertown, MA
    8 days ago
  • Senior Director, Global Regulatory Strategy, Oncology

    $196.7k - $353.4k

     ...The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This...  ...team. We believe in giving our people a platform to change medicine and an opportunity to change the world.... 
    Permanent employment
    Work at office
    Work from home

    Moderna

    Cambridge, MA
    1 day ago
  • Associate Director, Regulatory Affairs CMC
     ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure...  ...the needs of each partner. Lead, supervise and author all CMC sections... 

    Voyager Therapeutics, Inc.

    Cambridge, MA
    2 days ago
  • Associate Director, Regulatory Affairs CMC
     ...Therapeutics is a leading...  ...to the Head of Regulatory Affairs, you will...  ...the Regulatory CMC lead for these...  ...collaboration with CMC and global development teams...  ...technical changes and provide strategic...  ...:Associate Director:12+ Years of relevant...  ...three days on-site, creating a... 
    Contract work
    Remote work

    Crispr-Therapeutics-1

    Boston, MA
    4 days ago
  • Director, Regulatory CMC

    $196k - $240k

     ...Facebook . Role Summary The Director, Regulatory Affairs – Chemistry,...  ..., and Controls (CMC) is responsible for defining and executing global CMC regulatory strategies...  ...& Program Ownership Lead and execute global CMC...  ...commercial manufacturing changes Ensure alignment of... 
    Local area
    Worldwide

    Dyne Tx

    Waltham, MA
    3 days ago
  • Director, Regulatory Affairs CMC

    $207k - $253k

    ## Director, Regulatory Affairs CMCApplylocations: MA - Waltham...  ...shared purpose: leading the fight against...  ...regulatory CMC leadership to support...  ...topics.* Provides global regulatory input and...  ...assessments for change controls, deviations...  ...Madrigal Careers site. *Please be aware... 
    Minimum wage
    Full time
    Local area
    Flexible hours

    Madrigalpharma

    Waltham, MA
    4 days ago
  • Director, Regulatory Affairs CMC

    $207k - $253k

     ...strategic, tactical and operational regulatory CMC leadership to support...  ...Responsibilities Independently develop and lead execution of regulatory CMC...  ...for those meetings. Provide global regulatory input and support...  ...impact assessments for change controls, deviations and... 
    Full time
    Flexible hours

    Madrigal

    Waltham, MA
    2 days ago
  • Director, Global Regulatory Labeling Strategy

    $177k - $278.08k

     ...of what is possible in order to bring life‑changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible...  ...of Labeling Cross‑Functional Teams Leads Labeling cross‑functional teams providing leadership... 
    Full time
    Temporary work
    Local area
    Worldwide

    Takeda

    Boston, MA
    4 days ago
  • Director, Global Regulatory Labeling Strategy
    Join Takeda as the Director of Global Regulatory Labeling Strategy, based in Boston, MA. You will be responsible for developing and implementing labeling content and strategy for multiple products in various stages of drug development. The role requires 10+ years of pharmaceutical... 

    Takeda

    Boston, MA
    20 hours ago
  • Senior Director, Global Regulatory Affairs, Oncology

    $270k - $330k

     ...The Senior Director, Global Regulatory Affairs, Oncology is accountable for providing regulatory strategic...  ...associations where appropriate, and leads operational excellence initiatives within...  ...deliver more.Proven ability to lead change and communicate difficult messages... 
    Temporary work
    Local area
    Worldwide
    Flexible hours

    IPSEN

    Cambridge, MA
    2 days ago
  • Director, Global Regulatory Affairs, Neuroscience

    $177k - $278.08k

     ...boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for...  ...Global Program Teams. Defines, develops, and leads global strategies to maximize global regulatory... 
    Minimum wage
    Full time
    Temporary work
    Local area
    Remote work
    Worldwide

    Initial Therapeutics, Inc.

    Boston, MA
    4 days ago
  • Director, Global Regulatory Affairs, Neuroscience
    Job Description Director Global Regulatory Affairs, Neuroscience responsible for developing innovative global regulatory strategies and providing...  ...the Neuroscience Therapeutic Area Unit portfolio. This role leads product‑specific Global Regulatory Teams and represents the... 
    Local area

    JobRx, Inc.

    Boston, MA
    3 days ago
  • Sr. Manager, Regulatory Affairs, CMC

    $144.4k - $195.4k

    Overview The Senior Manager, Regulatory Affairs CMC Development is responsible for implementation of the global regulatory CMC strategy for...  ...This position reports to the Director of Regulatory Affairs CMC,...  ...developmental programs. Helps to lead the interpretation of... 
    Full time
    Temporary work
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Cambridge, MA
    3 days ago
  • Global Regulatory Submissions Director
    Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle...  ...partner with Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising & Promotion... 

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • Director, Global Regulatory Affairs Process Excellence and Transformation
    **Job Description**The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational...  ...across GRA.* Develop and implement change management plans, training,...  ...:**Hybrid-Eligible Or On-Site Eligible**Flex Eligibility Status... 
    Summer work
    Remote work
    Flexible hours
    2 days per week
    3 days per week

    Vertex Pharmaceuticals

    Boston, MA
    20 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Global Site CMC Director | Regulatory Change Lead. Be the first to apply!

Related searches