Global Regulatory CMC Lead
Hydrogen Group
A global healthcare firm is seeking a Regulatory CMC Lead in Boston, MA. The role requires expertise in regulatory strategy, operations, and planning for CMC aspects of assigned projects. Candidates should possess strong communication skills and a minimum of 3-5 years in the pharmaceutical industry. Responsibilities include managing Health Authority interactions and leading cross-functional teams. This position is vital for ensuring successful product submissions and regulatory compliance. #J-18808-Ljbffr Hydrogen Group
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory CMC Lead in Boston, MA vacancy
- SoTalent seeks a Senior Manager, Global Regulatory Affairs (CMC) to drive regulatory strategy and submissions for clinical development and post-approval. The role collaborates with development, QA, analytical, and manufacturing teams, ensuring alignment with global requirements...Regulatory
- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Regulatory
- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Regulatory
Katalyst CRO
Boston, MA3 days ago - ...International is seeking a Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves supporting... ...to navigate complex regulatory frameworks. You will lead global regulatory submissions and collaborate with cross-functional...Regulatory
$170k - $220k
A genetic medicine company in Boston is seeking an Associate Director of Regulatory CMC to lead regulatory strategy and bridge development with regulatory roles. This hybrid position requires strong regulatory affairs experience in biotechnology, excellent communication...Regulatory- Moderna seeks an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory CMC activities and developing strategies for transformative medicines. The ideal candidate will have at least 8 years in the biotech space, particularly...Regulatory
- BioSpace is seeking an Associate Director, Global Regulatory-CMC in Norwood, Massachusetts. This role involves coordinating regulatory activities and developing CMC strategies for product lifecycles. Candidates should possess a PhD in a relevant field and a minimum of 8...Regulatory
- GlaxoSmithKline is looking for a professional to lead CMC regulatory strategy in Cambridge, Massachusetts. The role involves working across teams to support timely access to medicines and ensure compliance with regulatory standards. Candidates should have a Bachelor’s degree...Regulatory
- Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this hybrid position, you will be responsible for implementing the global regulatory CMC strategy, shaping regulatory strategies for innovative modalities like oligonucleotide...Regulatory
- ...doing the right thing. Position Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects... ...vaccines, ensuring compliance with FDA expectations and global standards. Prepare and review technical...RegulatoryLocal area
- Initial Therapeutics, Inc. is seeking an Executive Director in Global Regulatory Affairs CMC Early Development to provide strategic leadership and development for regulatory strategies of small molecule and biologic products. You will oversee a team and align cross-functional...Regulatory
- Discover International is seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution. This role involves developing CMC strategies for complex pharmaceutical products and guiding major submissions. The...Regulatory
- Responsibilities Lead development and implementation of regulatory strategies for pure device and drug-device combination... .... Maintain and communicate CMC/quality guidance and regulations (... ...foundational subject matter expert for global Human Factors regulation for...RegulatoryNight shift
- Takeda in Boston, MA, seeks an experienced Regulatory CMC professional to lead submission planning and execution for clinical and post‑marketing programs. You will work with global teams to align regulatory strategy with product development goals. The role emphasizes regulatory...Regulatory
- Takeda is seeking an Executive Director for Global Regulatory Affairs CMC Early Development in Boston, MA. This leadership position involves strategic management of global CMC regulatory strategies for small molecules and biologics, from FIH to pre-pivotal development....Regulatory
- 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...Regulatory
$212k - $333.19k
...patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you... ...thereby driving prospective and proactive implementation. Globally influences and serves as a key opinion leader and...RegulatoryFull timeTemporary workLocal areaWorldwideNight shift$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading the integrated global regulatory strategies... ...assigned programs, ensuring alignment with clinical, CMC, and non-clinical development activities and overall program...RegulatoryLocal areaFlexible hours2 days per week- ...worldwide. About the Role This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational,...RegulatoryFull timeLocal areaWorldwide
$238k - $374k
...changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership... ...(e.g., US, EU, Japan, China). How You Will Contribute Leads and develops a team of regulatory leaders and subject matter...RegulatoryFull timeTemporary workLocal areaWorldwideJobRx, Inc.
Boston, MA3 days ago- A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages... ...with Small Molecule drugs, and a strong understanding of CMC requirements. Key responsibilities include managing submissions...Regulatory
- ...Takeda is looking for a Senior Director and Regulatory Platform Lead in Boston, MA, to lead the development of innovative regulatory strategies... ...responsible for guiding regulatory strategies, interfacing with global health authorities, and ensuring high-quality regulatory...Regulatory
Takeda
Boston, MA2 days ago - A global pharmaceutical company is seeking an Associate Director for Global Regulatory Affairs. This role involves acting as a Subject Matter Expert and managing all assigned programs while ensuring compliance with advertising and promotion regulations. Candidates should...RegulatoryRemote work
- A global pharmaceutical company seeks a Regulatory Affairs Specialist in Boston, MA. The role involves developing regulatory strategies for prescription drug submissions and managing lifecycle activities. Candidates should have a Bachelor's with 5+ years in regulatory...Regulatory
- Merck is seeking a Principal Scientist in Regulatory Affairs to develop and implement global regulatory strategies for vaccines and infectious disease projects. In this role, you will lead the Global Regulatory Team, ensuring compliance and timely approvals from regulatory...Regulatory
$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products... ...all submissions conform to health authority guidelines Lead Regulatory CMC discussions and interactions with health authorities...RegulatoryPermanent employmentWork at officeWork from home- ...Cambridge, Massachusetts is seeking a Director, CMC QA responsible for quality oversight in drug... ...thrive in a lean QA environment and support global clinical development programs through robust quality systems and regulatory adherence. #J-18808-Ljbffr Korro Bio, Inc.Regulatory
- GlaxoSmithKline in Cambridge, Massachusetts is seeking a Regulatory Affairs Manager to lead the Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for vaccines. This role requires expertise in FDA regulations, strong communication skills, and experience with...Regulatory
- A leading pharmaceutical company in Cambridge is seeking a Senior Director, Global Regulatory Lead for GI & Inflammation. This role is critical in ensuring compliance and securing regulatory approvals for new products. The ideal candidate will have over 12 years of experience...Regulatory
- Mass Digital Health is seeking a Global Regulatory Lead to develop and execute innovative regulatory strategies across its product portfolio. Based in either Morristown, NJ, or Cambridge, MA, this role is vital to ensure compliance with industry standards while advocating...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory CMC Lead. Be the first to apply!
Related searches