Regulatory CMC Lead, Gene Therapy — Global Submissions
$170k - $220kSolid Biosciences
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 skills, and the ability to work collaboratively across teams. The ideal candidate will handle CMC content for clinical trials and engage with agency interactions. The role offers competitive compensation between $170,000 and $220,000 along with extensive benefits. #J-18808-Ljbffr Solid Biosciences
- 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
- ...seeking an Associate Director for Global Submission Management to oversee strategic global regulatory submissions across development... ...on Pulmonary or Cell & Gene Therapy areas. You will ensure timely,... ...regulatory strategies. The role leads cross‑functional teams, manages...Regulatory
- ...Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position... ...execution for innovative biologic therapies. The ideal candidate will have... ...regulatory frameworks. You will lead global regulatory submissions and collaborate with cross-functional...Regulatory
- Takeda is seeking an experienced Regulatory CMC Leader in Boston to independently develop regulatory CMC strategy and lead regulatory submissions across the product lifecycle. You will partner with regulatory, development, and commercial teams to drive compliant, timely...Regulatory
$270k - $285k
A leading biotechnology firm in Somerville, Massachusetts... ...for a Senior Director, Regulatory CMC. This role is pivotal... ...defining and executing global CMC regulatory strategies for gene therapy products while ensuring... ...activities, regulatory submissions, and mentoring team...RegulatoryFull time- ...seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across... ...including Pulmonary or Cell & Gene Therapy areas. You will partner with... ...Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising...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
$190k - $240k
Orchard Therapeutics - U.S. is seeking a Regulatory Science expert to lead US regulatory strategy for gene therapy. The role involves collaboration with global teams to expedite FDA submissions while ensuring compliance across clinical development. Candidates should have...Regulatory- 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... ...position is vital for ensuring successful product submissions and regulatory compliance. #J-18808-Ljbffr...Regulatory
- ...seeking an experienced Associate Director / Director in Global Regulatory Affairs CMC to lead regulatory strategy and execution. This role involves... ...for complex pharmaceutical products and guiding major submissions. The ideal candidate will have over 10 years of experience...Regulatory
- Genetix Biotherapeutics is looking for a Director, Regulatory CMC to lead global regulatory strategies for gene therapy products. This full-time hybrid position based in Somerville, Massachusetts involves managing post-approval regulatory strategies and ensuring compliance...RegulatoryFull time
- 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
- Job Title: CMC Demand & Supply Leader Location... ...function, in the Global CMC Project... ...Projects in respect to Regulatory and Quality... ...Responsibilities Lead collaborative work... ...PCS) and Regulator submission/approval plans. Run... ...Immuno‑inflammation, Gene Therapy, Rare Diseases,...Regulatory
$212k - $333.19k
...delivers transformative therapies to patients. By focusing... ...role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...proactive implementation. Globally influences and serves as... ...aspects of global regulatory submissions (e.g., Core Dossiers,...RegulatoryFull timeTemporary workLocal areaWorldwideNight shift$163.2k - $244.8k
## Associate Director, Global Submission... ...a portfolio of global regulatory submissions across development... ...be Pulmonary or Cell & Gene Therapy.This role ensures routine... ...with Major Submission Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing,...RegulatorySummer workRemote workFlexible hours2 days per week- ...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
$211.5k - $258.5k
...and delivering category-leading precision therapies to transform the lives of... ...Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible... ...‑IND planning, IND/CTA submission strategy, Phase I/II/III... ...with clinical, CMC, and non‑clinical development...RegulatoryLocal areaFlexible hours2 days per week$238k - $374k
...and delivers transformative therapies to patients. By focusing R... .... As Executive Director, Global Regulatory Affairs CMC Early Development you will... .... How You Will Contribute Leads and develops a team of... ...regulatory strategy and key submissions/health authority interactions...RegulatoryFull timeTemporary workLocal areaWorldwide$137k - $215.27k
...delivers transformative therapies to patients. By... ...This role is within the Global Regulatory Affairs (GRA) Chemistry... ...Manufacturing & Controls (CMC) and Devices... ...With some supervision, leads the execution of regulatory... ...of robust and accurate submissions. Develops constructive...RegulatoryMinimum wageFull timeTemporary workLocal areaWorldwide- ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at... ...drugs, and a strong understanding of CMC requirements. Key responsibilities include managing...Regulatory
- 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 affairs...Regulatory
- ...Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this... ...be responsible for implementing the global regulatory CMC strategy, shaping... ...Alnylam to help bring groundbreaking therapies to patients. #J-18808-Ljbffr Alnylam...Regulatory
$208.2k - $327.14k
A leading global R&D organization is seeking a Senior Director, Global Regulatory Lead - Oncology. This role involves leading global regulatory... ...of innovative oncology therapies. The successful candidate... ...strong background in regulatory submissions. The position is based in...Regulatory- Takeda is seeking a Senior Director, Global Regulatory Lead for Oncology in Boston, MA. This role... ...responsibilities that include overseeing FDA submissions and ensuring compliance with... ...in oncology and help bring innovative therapies to patients. #J-18808-Ljbffr JobRx,...Regulatory
- Sionna Therapeutics is seeking an experienced Regulatory Affairs leader to drive CMC regulatory strategy across its evolving clinical‑stage pipeline. The role requires coordinating global submissions, authoring CMC sections, and shaping regulatory strategy with QA, Clinical...Regulatory
- Sanofi Inc. in the United States is seeking a Global Submission Manager to oversee global submission types across a diverse portfolio. You will represent GRO on Global Regulatory Teams, coordinate submission planning, and negotiate timelines with key stakeholders to ensure...Regulatory
$148.5k - $214.5k
Sanofi is seeking a CMC dossier leader to manage the preparation and development processes within the... ...CMC Dossier Sciences team. This role focuses on leading cross-functional teams and ensuring timely regulatory submissions while leveraging digital tools and AI solutions....Regulatory$177k - $278.08k
Takeda is seeking a Director, Global Regulatory Lead Oncology to oversee regulatory activities for oncology programs in Boston, MA. This role involves managing FDA submissions and setting global regulatory strategies. Ideal candidates will have 8+ years of pharmaceutical...Regulatory- Takeda is seeking an Associate Director, Global Regulatory Lead Oncology in Boston, MA. This role... ...oncology programs, overseeing major submissions, and guiding cross-functional teams to... ...Join us to contribute to transformative therapies for patients worldwide. #J-18808-...RegulatoryWorldwide
$212k - $333.19k
...innovation and delivers transformative therapies to patients. By focusing R&D efforts... .... Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of... ...manner. Accountable for US FDA submissions and approvals of project(s) of responsibility...RegulatoryMinimum wageTemporary workLocal areaWorldwide
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