CMC Regulatory Strategy Lead — Biologics (Remote)
Travere Therapeutics
- Remote job
Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for global CMC activities across development and commercial programs, with a focus on biologics and rare diseases. You will partner with cross-functional teams to align CMC plans with regulatory requirements, lead global submissions (INDs, NDAs), and drive lifecycle management from late development through post-approval. #J-18808-Ljbffr Travere Therapeutics
- Travere Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across development and commercialization. You will partner with cross-functional teams to align CMC plans with regulatory requirements...Remote jobRegulatory
- Travere Therapeutics in San Diego seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for biologics across development and commercialization. The role emphasizes late-stage programs and rare diseases, coordinating cross-functional teams...Remote jobRegulatory
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for biologics across development and commercialization. The role leads global CMC strategies, drives submissions, and partners with Regulatory,...Remote jobRegulatory
- ...seeks an experienced Associate Director, CMC Regulatory Affairs to provide strategic... ...development and commercial programs. You will lead global submissions for biologics, interact with Health Authorities, and guide lifecycle strategies while collaborating with multiple...Remote jobRegulatory
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to lead strategic regulatory activities for biologics, supporting development through commercialization. The role collaborates with Technical Operations, Manufacturing, Quality, and Development...Remote jobRegulatory
- ...Pharmaceuticals is seeking a high-caliber Associate Director, Regulatory Affairs to lead regulatory strategies for novel biologics or drugs in early development. This role reports... ...can be based out of a Tonix office or fully remote. It offers a comprehensive compensation and...Remote workRegulatoryWork at office
- ...seeking an Associate Director for Regulatory Affairs CMC to oversee regulatory strategies for innovative gene therapies.... ...CMC regulatory requirements for biologics and gene therapies. The ideal... ...work environment with flexible remote options. #J-18808-Ljbffr Jobleads...Remote workRegulatoryFlexible hours
- Astellas in Westborough, MA is seeking a senior Regulatory CMC leader to develop and drive global CMC regulatory strategy and submissions. You will collaborate with RA,... ...for NMEs and changes. This role requires a BS in Biology or equivalent with 10 years in the pharma...Remote jobRegulatory
- Rezolute, Inc. seeks a Sr Director of Regulatory Affairs to lead late-stage regulatory strategy and execution for rare disease biologics. You will drive FDA interactions and U.S. registrations... ...requires deep expertise in biologics, CMC, and global regulatory affairs, with a...Regulatory
- Jazz Pharmaceuticals, Inc. is seeking a Senior Manager, Regulatory Affairs Global CMC to lead regulatory CMC support for biological products worldwide, including submissions and strategy development. The role collaborates with the Global Regulatory Team, external partners...RegulatoryWorldwide
$238k - $374k
...group of experienced biologic drug hunters with... ...resources of a leading pharmaceutical company... ...the program strategy for antibody, bispecific... ..., clinical, CMC, and commercial considerations... ...acumen including regulatory (BLA/MAA pathway)... ...’s Hybrid and Remote Work policy.Takeda...Remote workRegulatoryMinimum wageTemporary workLocal area$227.42k - $275.58k
...expertise and resources of a leading innovator in oncology... ...leader to lead our biology organization. This... ...establish biology strategies across the discovery... ...Clinical Pharmacology, Regulatory, and CMC teams.Ensure biology... ...centers. Employees in remote-by-design or lab-...Remote workRegulatoryHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startFlexible hours- Humacyte Inc. seeks a Senior Associate, Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role supports strategy, compliance, and submissions for complex manufacturing processes and reports to the Head of Product...Remote jobRegulatory
- Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for biologics across development and commercial programs. You will drive global CMC strategies, author Module 2/3 content, and coordinate with...Remote jobRegulatory
- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role... ...CMC activities and developing strategies for transformative medicines. The ideal... ...in the biotech space, particularly in biologics-focused regulatory CMC. The position offers...Regulatory
$144.06k - $205.8k
...leadership role in the Regulatory Affairs department... ...and Controls (CMC) aspects of... ...global CMC regulatory strategy (e.g., CMC strategy... ...a CMC regulatory lead for highly complex... ...Qualifications BS in Biology or equivalent... ...Westborough, MA. Remote work from anywhere...Remote workRegulatoryWork at officeLocal areaWork from homeWorldwide- ...in New York seeks a Senior Director, Biologics CMC to lead scientifically and operationally from... ...manufacturing, analytics, quality and regulatory CMC. This collaborative leader will... ...documents, and drive integrated CMC strategies with cross-functional teams in a lean...Regulatory
$150k - $195k
...vision of becoming a leading biopharmaceutical company... ...Associate Director, CMC Regulatory Affairs is responsible... ...global CMC regulatory strategies to support clinical development... ...activities for biologic products, with a... ...is expected to be 100% remote.Total Rewards Offerings...Remote workRegulatoryFull timeTemporary work- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical...Regulatory
$132k - $172k
...vision of becoming a leading biopharmaceutical company... ...:The Senior Manager, CMC Regulatory Affairs is responsible... ...global CMC regulatory strategies to support clinical... ...management activities for biologic products, with a... ...is expected to be 100% remote.Total Rewards Offerings...Remote workRegulatoryFull timeTemporary workWorldwide- Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule... ...drug products across development and commercialization. Lead CMC strategies, author Module 2/3, and coordinate cross-functional teams...Remote jobRegulatory
- NewAmsterdam Pharma Corporation is seeking a Senior Manager CMC Regulatory Affairs to oversee global CMC regulatory strategies for clinical development programs and marketing applications. The role is remote and emphasizes collaboration with various departments to ensure...Remote jobRegulatory
- ...DirectorJob Description - CMC Team Leader, Sr.... ...two complementary strategies which aim to... ...autoimmune diseases. The lead CARTA (Chimeric... ...: [Remote]Department: Technical... ...commercial-stage biologic products. This individual... ...Manufacturing, Quality, Regulatory Affairs, Supply...Remote workRegulatory
- Parexel is seeking a Regulatory Strategy Consultant to lead regulatory strategy across major programs in a remote capacity in the United States. You will shape regulatory pathways... ...regulatory affairs experience, vaccine/biologic knowledge, and the ability to influence stakeholders...Remote jobRegulatory
- Neurona Therapeutics is seeking a Senior Manager or Associate Director in Regulatory Affairs (CMC) to lead regulatory strategy for cell therapies and guide submissions. This remote-friendly role reports to the Head of Regulatory Affairs in a fast-growing CNS-focused company...Remote jobRegulatory
- Syneos Health is seeking a Regulatory CMC Manager for Cell and Gene Therapy to lead global regulatory CMC strategies and submissions for marketed and development products. You will collaborate with cross-functional teams to ensure global regulatory requirements are met...Remote jobRegulatory
- Travere Therapeutics in San Diego seeks a Senior Manager, CMC Regulatory Affairs to lead regulatory strategy for chemistry, manufacturing, and controls across development and commercial programs. You will partner with Development, Operations, Quality, and Regulatory due...Remote jobRegulatory
- Tonix is seeking a full-time Associate Director, Regulatory Affairs to lead regulatory strategies for novel biologics or drugs in early development, from pre-IND... ...Management and Execution, and can be based in a Tonix office or remotely. #J-18808-Ljbffr Tonix PharmaceuticalsRemote jobRegulatoryFull timeWork at office
$169.5k - $248.6k
...About the RoleAs the Global Regulatory Lead (GRL), you will be the accountable... ...of global regulatory strategies— from portfolio entry through... ...of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global... ...and relocation is provided, remote is not available for this role...Remote workRegulatoryLocal areaRelocationFlexible hours$111k - $149k
Biogen in the United States is seeking a Senior Regulatory CMC Device and Combination Product Lead to provide regulatory expertise for global strategies, with focus on device and combination products. You will collaborate with cross-functional teams, lead regulatory submissions...Remote jobRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Strategy Lead — Biologics (Remote). Be the first to apply!
- food regulatory San Diego, CA
- regulatory engineer San Diego, CA
- regulatory accountant San Diego, CA
- regulatory San Diego, CA
- regulatory cmc San Diego, CA
- regulatory technician San Diego, CA
- clinical research regulatory San Diego, CA
- regulatory coordinator San Diego, CA
- regulatory law San Diego, CA
- regulatory executive San Diego, CA
