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

Remote Director of CMC Regulatory Affairs (Biologics)

Brunel

Brunel is seeking a Director, Regulatory Affairs CMC – Biologics who will provide strategic and operational leadership across biologics programs throughout the product lifecycle. This full-time role is suited for a senior-level consulting professional with deep CMC biologics expertise and strong client-facing skills. The ideal candidate will manage CMC regulatory activities, author CMC sections, and support health authority interactions while mentoring teams. Strong project leadership skills and a Bachelor’s degree in a relevant field are essential. This opportunity offers a chance to work fully remote, with a focus on delivering high-quality regulatory outcomes. #J-18808-Ljbffr

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Remote Director of CMC Regulatory Affairs (Biologics) in Richmond, CA vacancy
  •  ...Brunel is recruiting a Director, Regulatory Affairs CMC – Biologics to provide strategic leadership across biologics programs throughout the product lifecycle. This full-time opportunity is fully remote, aimed at experienced professionals with strong client-facing skills... 
    Remote work
    Full time

    Brunel

    New York State
    2 days ago
  • $274.8k - $354.8k

     ...BeiGene, Ltd. is seeking an Executive Director of Regulatory Affairs, CMC, to lead the U.S. Biologics Regulatory team. This pivotal role includes strategic leadership of regulatory activities for biologics, ensuring compliance and high-quality submissions across the product... 
    Remote work

    BeiGene

    New York, NY
    3 days ago
  •  ...therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant...  ...modalities—including small molecules, biologics, and external manufacturing sites—the...  ...currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.... 
    Remote work
    Worldwide

    Takeda

    Cambridge, MA
    3 days ago
  • Associate Director or Director CMC Regulatory Affairs Job Title: Associate Director or Director, CMC Regulatory...  ...Reports To: VP of Regulatory Location: Remote or Onsite Position Summary: The...  ...to gene therapy and advanced biologics. • Interpret regulatory requirements... 
    Remote work
    Contract work

    Atsena Therapeutics

    Durham, NC
    3 days ago
  • Director, Regulatory Affairs - CMC ICON plc is a world-leading healthcare intelligence and clinical research...  ...Location The position may be remote based across the US, or East Coast preferred...  ...of small and large molecules (Biologics [mAb, bSAb & Recombinant Protein,... 
    Remote work
    Local area
    Flexible hours

    ICON Clinical Research

    Blue Bell, PA
    2 days ago
  • $133.2k - $172.37k

     ...Kite Manager, Global Regulatory CMC Kite, as part of Gilead, is dedicated...  ..., and Global Regulatory Affairs. Kite is transitioning from...  ...balanced approach with two days of remote working and three days...  ...g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related... 
    Remote work
    For contractors
    Work at office
    Local area
    Relocation
    Flexible hours

    Kite Pharma

    El Segundo, CA
    1 day ago
  • $133.2k - $172.37k

     ...come. ** The Manager, Global Regulatory CMC will support Kite’s...  ...Manufacturing, and Global Regulatory Affairs. Kite is transitioning from...  ...approach with two days of remote working and three days working...  ...g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related... 
    Remote work
    For contractors
    Work at office
    Local area
    Relocation
    Flexible hours

    Gilead Sciences

    El Segundo, CA
    4 days ago
  •  ...BioSpace is looking for a Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) to prepare regulatory strategies for biologics. This role involves significant collaboration with internal partners and regulatory agencies to streamline product delivery... 

    BioSpace, Inc.

    Waltham, MA
    1 day ago
  • $213k - $240k

     ...Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic...  ..., and positive company culture. Job Title: Director / Senior Director, Regulatory CMC (Biologics) Location: Hybrid - Waltham, MA... 
    Work at office
    3 days per week

    Oruka Therapeutics

    Waltham, MA
    2 days ago
  •  ...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide...  ...strategies for small molecule and biologic products for FIH to pre-pivotal...  ...currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.... 
    Remote work
    Worldwide

    Takeda

    Cambridge, MA
    1 hour ago
  •  ...Director, Regulatory Affairs CMC (Biologics, Combination Products) Date: May 20, 2026 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 66871 We Are Teva We’re Teva, a leading innovative biopharmaceutical... 
    Local area
    Worldwide
    Flexible hours

    Teva Pharmaceuticals

    West Chester, PA
    4 days ago
  • Title: Associate Director/Director, Regulatory CMC Location: North Carolina/Remote If you are interested in the below position, please send your resume tocareers...  ...manufacturing, and quality control. Experience with biologics and combination products required; experience... 
    Remote work
    Contract work

    TG Therapeutics, Inc.

    Raleigh, NC
    15 hours ago
  • $148.5k - $257.4k

     ...provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities...  ...Engineering, Analytical Sciences, Biology, or similar. 10+ years of Regulatory CMC...  ...Position Location: Indianapolis, IN. A remote option may be considered. Relocation assistance... 
    Remote work
    Full time
    Relocation package
    Flexible hours

    Eli Lilly and Company

    Indianapolis, IN
    2 days ago
  • $180k - $210.5k

     ...make the most complex biologics ever attempted to protect...  ...multi-product global regulatory CMC strategies for...  ...Pharmacy, Regulatory Affairs for Drugs, Biologics or...  ...Reports to: Executive Director, CMC Regulatory Location...  ...San Carlos, CA / US Remote Work Arrangement:... 
    Remote work

    Vaxcyte

    San Carlos, CA
    5 days ago
  • Neurocrine Biosciences in San Diego, California is seeking a Regulatory Affairs professional to lead CMC regulatory strategy and ensure compliance for biologics. With a strong focus on collaboration and communication, the role entails managing regulatory submissions to... 

    Neurocrine Biosciences

    San Diego, CA
    3 days ago
  • $176.4k - $228.25k

     ...Associate Director, CMC Regulatory Affairs New York, New York; Salt Lake City, Utah Your Work Will Change...  ...is ideal; however, we will consider remote work for this position. We ask that...  ...-stage TechBio company decoding biology to radically improve lives. Recursion... 
    Remote work
    Local area
    Work from home
    Worldwide

    Recursion Pharmaceuticals

    United States
    4 days ago
  • $157.2k - $256.6k

     ...Associate Director, Global CMC Regulatory Strategy As an Associate Director you...  ...stages, mentor CMC Regulatory Affairs (RA) staff, supporting...  ...2 days from home. A fully remote role is not possible for this...  ...marketing of drugs and/or biologics. Lead and facilitate... 
    Remote work
    Work at office
    Worldwide
    Relocation package
    3 days per week

    Regeneron

    Tarrytown, NY
    2 days ago
  • $185k - $200k

     ...Associate Director Of Regulatory Affairs, Cmc The associate director of regulatory affairs, cmc plays a...  ...regulations and guidelines applicable to biologics and cell/gene therapy, including fda...  ...preferred; highly qualified remote candidates will be considered.... 
    Remote work
    Flexible hours

    Artiva Biotherapeutics

    San Diego, CA
    2 days ago
  • $157.2k - $256.6k

     ...As an Associate Director you will lead the development...  ...execution of global CMC regulatory strategies for the hematology...  ...mentor CMC Regulatory Affairs (RA) staff, supporting...  ...from home. A fully remote role is not possible...  ...of drugs and/or biologics. • Lead and facilitate... 
    Remote work
    Work at office
    Local area
    Worldwide
    Relocation package
    3 days per week

    Regeneron Pharmaceuticals

    Tarrytown, NY
    3 days ago
  •  ...GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute...  ...develops and leads the execution of regulatory CMC investigational, registration and/or...  ...classified as "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid... 
    Remote work
    Worldwide

    Takeda

    Cambridge, MA
    3 days ago
  •  ...Director Us Regulatory Affairs The Director US Regulatory Affairs supports the contract...  ...MS or PhD in chemistry or biology and/or Regulatory Affairs...  ...and Manufacturing Control (CMC) Regulatory experience is a...  ...with face to face and remote teams. Minimum Required... 
    Remote work
    Contract work

    KMR Search Group

    Passaic, NJ
    2 days ago
  •  ...Regulatory Affairs Manager, Biologics/Senior Regulatory Affairs Manager, Biologics United Therapeutics seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter... 
    Remote work
    Local area
    Relocation package
    1 day per week

    IVIVA Medical

    United States
    2 days ago
  • $285k - $320k

     ...Sr. Director, Regulatory Affairs - CMC San Francisco - 1800 Owens Mavericks Wanted When was the last time you achieved the impossible? If that...  ...Where You'll Work This is a U.S.-based remote role that will require quarterly, or as needed visits to... 
    Remote work
    Work at office
    Flexible hours

    BridgeBio

    United States
    2 days ago
  • $191.25k - $247.5k

     ...Director, Global Regulatory Affairs CMC At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary...  ...policy, offering a balanced approach with two days of remote working and three days working onsite. Key Responsibilities... 
    Remote work
    Work at office
    Relocation
    Flexible hours
    Shift work

    Kite Pharma

    Oceanside, CA
    5 days ago
  • $177k - $278.08k

     ...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to...  ...as "hybrid" following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation... 
    Remote work
    Minimum wage
    Full time
    Temporary work
    Local area
    Worldwide

    Takeda Pharmaceutical Company Ltd

    Boston, MA
    1 day ago
  • $137k - $215.27k

     ...patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to...  ...as hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda... 
    Remote work
    Minimum wage
    Full time
    Temporary work
    Local area
    Immediate start
    Worldwide

    Takeda Pharmaceutical Company Ltd

    Cambridge, MA
    1 day ago
  • $221k - $286k

     ...Overview Senior Director, Regulatory CMC – CAR T Cell Therapy provides global leadership and strategic...  ..., Quality, Global Regulatory Affairs, and external partners to enable compliant...  ...flexible working policy with two days of remote work and three days onsite. Key Responsibilities... 
    Remote work
    For contractors
    Relocation
    Flexible hours

    Kite Pharma

    Oceanside, CA
    14 hours ago
  • $221k - $286k

     ...patients for generations to come. The Senior Director, Regulatory CMC - CAR T Cell Therapy provides global...  ..., Quality, Global Regulatory Affairs, and external partners to enable compliant...  ...a balanced approach with two days of remote working and three days working onsite... 
    Remote work
    For contractors
    Work at office
    Local area
    Relocation
    Flexible hours

    Gilead Sciences

    San Mateo, CA
    4 days ago
  • $115k - $145k

     ...Therapeutics is seeking a Manager/Senior Manager, Regulatory CMC. This role provides regulatory...  ...The role will report to the Executive Director, Regulatory CMC. This role is...  ...consider candidates who are looking for fully remote roles. Job Responsibilities... 
    Remote work
    Work at office
    Local area
    3 days per week

    Axsome Therapeutics, Inc.

    New York, NY
    5 days ago
  • $125k - $145k

     ...firm focused on bladder cancer treatment seeks a Manager of Regulatory Affairs. This remote role requires overseeing regulatory strategies and...  ...degree, five years of regulatory experience, and knowledge of CMC and clinical requirements. The position offers a competitive... 
    Remote work
    Flexible hours

    CG Oncology, Inc.

    New York, NY
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Remote Director of CMC Regulatory Affairs (Biologics). Be the first to apply!