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

Associate Director, CMC Regulatory Affairs - Global Submissions (Remote)

Ionis-Pharmaceuticals

Ionis Pharmaceuticals, Inc. in Carlsbad, CA, is seeking an Associate Director of CMC Regulatory Affairs to establish and execute global CMC regulatory strategies for commercial compounds. The role collaborates with cross-functional teams, partners, and vendors to deliver accurate regulatory documentation within timelines and to liaison with authorities for timely approvals. The candidate will lead complex submissions, oversee post-approval changes, and maintain current knowledge of applicable

#J-18808-Ljbffr
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Associate Director, CMC Regulatory Affairs - Global Submissions (Remote) in Carlsbad, CA vacancy
  • $154.4k - $242.55k

     ...worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization,...  ...of robust and accurate submissions.Develops constructive relationships...  ...Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI-AA1... 
    Remote work
    Minimum wage
    Local area
    Worldwide

    Takeda

    Boston, MA
    1 day ago
  • $164k - $213k

     ...Associate Director, Regulatory Affairs CMC At Insmed, every moment and every patient counts...  ...who joins in. As a global biopharmaceutical company...  ...and coordinate regulatory submissions to support projects in development...  ...Work This is a fully remote role. It can be performed... 
    Remote work
    Temporary work
    Flexible hours

    Insmed

    United States
    2 days ago
  •  ...the better. Chiesi Global Rare...  ...doCurrently seeking a Regulatory Affairs (RA) Manager with strong CMC pre and post approval...  ...a broad range of submissions to Regulatory Authorities...  ...functions and Senior Director or Reg CMC Lead,...  ...arrangements, remote work options, and... 
    Remote work
    Hourly pay
    Work at office
    Local area
    Relocation package
    Flexible hours

    Chiesi

    Cary, NC
    3 days ago
  • $181.16k - $224.72k

     ...making our onsite, hybrid and remote work environments a place...  ...employees can thrive. ASSOCIATE DIRECTOR, CMC REGULATORY AFFAIRS Summary This individual’s...  ...to establish and execute global CMC regulatory strategies...  ...requirements for global submissions, (2) work independently... 
    Remote work

    Ionis Pharmaceuticals, Inc.

    Carlsbad, CA
    5 days ago
  • ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations...  .... As the Regulatory CMC lead for these...  ...collaboration with CMC and global development teams,...  ...requirements for submission to US and ex-US regulatory...  ...that balances remote work flexibility with... 
    Remote work
    Contract work

    CRISPR Therapeutics

    Boston, MA
    1 day ago
  • General Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting...  ...Schedule: Full time Remote Work: In office Job: RI...  ...responsible for leading the global regulatory CMC strategy...  ...CMC documentation and submissions in adherence to relevant... 
    Remote work
    Permanent employment
    Full time
    Temporary work
    Work at office

    Orano Med, LLC.

    Plano, TX
    1 day ago
  • $142.5k - $256.5k

    The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing...  ...and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the... 
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Norwood, MA
    2 days ago
  • Angitia Biopharmaceuticals seeks a Director of Global Regulatory Affairs to drive regulatory strategy for development...  ...programs, coordinating with clinical, CMC, safety, statistics, and operations. You will lead global submissions and health authority interactions, guiding... 
    Remote job

    Angitia Biopharmaceuticals

    Los Angeles, CA
    3 days ago
  •  ...is seeking a highly technical Regulatory Affairs Manager / Senior Manager in...  ...Gaithersburg, MD for a 100% hands-on CMC role. The position is hybrid...  ...author and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The... 

    Green Key Resources

    Gaithersburg, MD
    3 days ago
  • $135.3k - $202.9k

     ...advancement across the globe.Scope: The Associate Director, Global Regulatory Affairs Lead is responsible for the...  ...regulatory sub-team.Drive the regulatory submission in your respective region. Ensure...  ...with Monday and Friday offered as remote flexible.Pay Range for this... 
    Remote work
    Local area
    Monday to Friday
    Flexible hours

    Merck

    Billerica, MA
    3 days ago
  • $154.4k - $242.55k

     ...for the delivery of global regulatory strategies to support...  ...required maintenance submissions/notifications to ensure...  ...Global Regulatory Affairs (GRA) function in senior...  ...and supporting trade association working groups....  ...communicationLocation: Remote within the USTakeda Compensation... 
    Remote work
    Minimum wage
    Local area

    Takeda

    Boston, MA
    1 day ago
  • $142.5k - $256.5k

    The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing...  ...and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the... 
    Permanent employment
    Work at office
    Local area
    Work from home

    Moderna Therapeutics

    Norwood, MA
    5 days ago
  • $235k - $280k

     ...Job Title: Senior Director, Global Regulatory Affairs Reports to (Title): VP, Hengrui...  ...Hybrid for NJ/MA candidates & Remote for out-of-state Job...  ...NDA, BLA, and MAA submissions, providing an exceptional...  ...clinical pharmacology, and CMC, ensuring integrated regulatory... 
    Remote work
    Full time
    Monday to Friday

    Hengrui USA

    United States
    9 hours ago
  • $150k - $210k

     ...position will contribute regulatory CMC experience to Edgewise cardiovascular...  ...needed for regulatory submission activities for US and global assigned products. The...  ...with Regulatory Affairs, CMC, and Quality to ensure...  ...experience working in a remote environment. ~ Able to... 
    Remote work
    Full time
    For contractors

    Edgewise Therapeutics

    Remote
    10 days ago
  • $284k - $302k

     ...Diego, CAClinical - Regulatory /Full-Time /HybridThe Senior Director, Global Regulatory Affairs will provide strategic...  ...including Clinical, CMC, Biometrics, and Translational...  ...(CTR) and CTA submissions.Serve as the primary...  ...in San Diego office. Remote permitted upon approval... 
    Remote work
    Full time
    Summer work
    Work at office
    Relocation
    Relocation package
    Shift work

    Janux Therapeutics

    San Diego, CA
    1 day ago
  • $222k - $303k

     ...person who joins in. As a global biopharmaceutical company...  ...We’re looking for a Senior Director, Regulatory Affairs CMC - Gene Therapy to help us...  ...quality, compliant, on-time submission activities for initial...  ...You’ll Work This is a fully remote role. It can be performed... 
    Remote work
    Full time
    Local area
    Flexible hours

    Insmed

    Trenton, NJ
    2 days ago
  • $189.7k - $237.1k

     ...Join Acadia as the Director, Regulatory CMC and play a critical role...  ...develop and execute global regulatory CMC strategies...  ...the CMC regulatory affairs activities for...  ...MAAs and amendments for submission to regulatory authorities...  ...independently from remote locations. The employee... 
    Remote work
    Full time
    Work at office
    Local area
    Worldwide
    Shift work
    Night shift
    Day shift
    3 days per week

    ACADIA Pharmaceuticals

    Princeton, NJ
    2 days ago
  • $180k - $230k

     ...Position: Director, Global Regulatory Affairs Department: Development - Regulatory...  ...Affairs Location: U.S (Remote) with up to 20% domestic travel...  ...Development, Nonclinical, CMC, Safety, Biostatistics,...  ...of major regulatory submissions, including INDs, CTAs, amendments... 
    Remote job
    For contractors
    Work from home
    Overseas

    Jobleads-US

    Kentucky
    5 days ago
  • Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across small molecule and biologics. This...  ...requires 10+ years in biopharma with deep global HA regulatory experience, an advanced... 

    USA - 3316 Takeda Development Center Americas, Inc.

    Cambridge, MA
    5 days ago
  • Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications. The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory... 
    Work at office
    Worldwide

    Regulatory Jobs

    Norwood, MA
    5 days ago
  • $166.4k - $249.6k

     ...Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across...  ...-quality regulatory submissions, while serving as the...  ...Pharmacy, Regulatory Affairs, or related life science...  ...designated as: 1. Hybrid: work remotely up to two days per... 
    Remote work
    Full time
    Summer work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    9 hours ago
  • $230k - $270k

     ...seeking a highly motivated Senior Director, CMC Regulatory Affairs in the Global Regulatory Affairs and Clinical Quality...  ...requirements and regulatory submissions are on time and high quality. The...  ...in South San Francisco and may be remote up to 2 days per week. Responsibilities... 
    Remote work
    Full time
    Contract work
    Internship
    Local area
    2 days per week

    Allogene Therapeutics

    South San Francisco, CA
    24 days ago
  • $154.4k - $242.55k

     ...worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will...  ...programs, oversee major submissions, and guide cross-...  ...concepts within regulatory affairs and implications across the...  ...following Takeda's Hybrid and Remote Work policy.#LI-Hybrid#LI... 
    Remote work
    Minimum wage
    Local area
    Worldwide

    Takeda

    Boston, MA
    9 hours ago
  • $222k - $303k

     ...person who joins in. As a global biopharmaceutical company...  ...We’re looking for a Senior Director, Regulatory Affairs CMC to help us expand what’s possible...  ..., and manage regulatory submissions for compounds in various...  ...Work This is a fully remote role. It can be performed... 
    Remote work
    Full time
    Local area
    Worldwide
    Flexible hours

    Insmed Incorporated

    Remote
    20 days ago
  • Enigma Search in the United States is seeking a Director, Regulatory CMC to lead global regulatory activities for small molecules and monoclonal antibodies...  ...with CMC, Quality, and Manufacturing teams to prepare submissions (NDA, BLA, MAAs), maintain the CTD, ensure regulatory... 

    Enigma Search

    South San Francisco, CA
    3 days ago
  • $189.5k - $235k

    Vacancy Name Director, Regulatory Affairs-Global Regulatory Lead Vacancy No...  ...Radnor, PA, Oxford, UK, Remote, US Department...  ...development, IND development/submission /maintenance, BLA/...  ...activities associated with the project teams...  ...trial labelling and CMC submissions for regulatory... 
    Remote work
    Full time
    Work at office
    Local area
    Worldwide
    Night shift

    BioSpace

    Gaithersburg, MD
    5 days ago
  • $222k - $303k

     ...person who joins in. As a global biopharmaceutical...  ...looking for a Senior Director, Regulatory Affairs, Global Regulatory...  ...clinical, nonclinical, CMC, safety, commercial,...  ...objectives of major global submissions and Health Authority...  ...This is a fully remote role. It can be performed... 
    Remote work
    Full time
    Local area
    Flexible hours

    Insmed Incorporated

    Remote
    4 days ago
  • $170.9k - $231.3k

    OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This...  ...strategies. Experience with regulatory submissions and health authority interactions for... 
    Full time
    Temporary work
    Work at office
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Philadelphia, PA
    4 days ago
  • $177.4k - $238.96k

     ...Position OverviewImmunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across...  ...ensure adherence to accelerated regulatory submission schedules. Reporting into the Senior Director... 
    Flexible hours

    Immunome

    Bothell, WA
    1 day ago
  • JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development...  ...-quality CMC content for regulatory submissions, provide phase-appropriate... 
    Work at office
    Flexible hours

    Iambic Therapeutics

    San Diego, CA
    9 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Associate Director, CMC Regulatory Affairs - Global Submissions (Remote). Be the first to apply!