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
- ...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 workFull time
$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- ...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 workWorldwide
- 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 workContract work
- 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 workLocal areaFlexible hours
$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 workFor contractorsWork at officeLocal areaRelocationFlexible hours$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 workFor contractorsWork at officeLocal areaRelocationFlexible hours- ...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...
$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 office3 days per week- ...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 workWorldwide
- ...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 areaWorldwideFlexible hours
- 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 workContract work
$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 workFull timeRelocation packageFlexible hours$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- 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...
$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 workLocal areaWork from homeWorldwide$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 workWork at officeWorldwideRelocation package3 days per week$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 workFlexible hours$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 workWork at officeLocal areaWorldwideRelocation package3 days per week- ...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 workWorldwide
- ...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 workContract work
- ...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 workLocal areaRelocation package1 day per week
$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 workWork at officeFlexible hours$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 workWork at officeRelocationFlexible hoursShift work$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 workMinimum wageFull timeTemporary workLocal areaWorldwide$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 workMinimum wageFull timeTemporary workLocal areaImmediate startWorldwide$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 workFor contractorsRelocationFlexible hours$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 workFor contractorsWork at officeLocal areaRelocationFlexible hours$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 workWork at officeLocal area3 days per week$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 workFlexible hours
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