Regulatory CMC Director — Lead Global Submissions (Hybrid)
Rhythm Pharmaceuticals Inc.
Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical Operations, and Quality, and ensure timely, compliant submissions across development, commercialization, and lifecycle events. The role requires extensive experience with peptides/injectables, and a proven ability to manage #J-18808-Ljbffr Rhythm Pharmaceuticals Inc.
$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA)... ...Manufacturing & Controls (CMC) and Devices organization... ...the GRA CMC Franchise Lead for TAK-079 Independently... ...global registrational submissions of a complex drug... ...currently classified as "hybrid" following Takeda's...SuggestedMinimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...Pharmaceuticals in Boston seeks a Director, Global Submission Management to lead global regulatory submissions across development... ...and coordinating with Strategy, CMC, Labeling, Publishing, and Advertising... ...Smartsheet, and Veeva RIM in a hybrid work environment. #J-18808-...Suggested
- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies... ...CMOs to align with FDA/EMA expectations and global health authority standards. The role requires deep CMC...Suggested
- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging AI-enabled... ...ability to lead cross-functional teams in a hybrid Boston-area setting. #J-18808-Ljbffr Vertex...Suggested
$238k - $374k
...Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you... ...regulatory strategies and submissions for small molecule and biologic... ...China).ACCOUNTABILITIES Leads and develops a team of... ...currently classified as “hybrid” in accordance with...SuggestedMinimum wageTemporary workLocal areaRemote work$238k - $374k
...patients worldwide.As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ....How you will contribute:Leads and develops a team of... ...strategy and major submissions for an assigned portfolio... ...currently classified as "hybrid" following Takeda's Hybrid...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$211.5k - $258.5k
...delivering category‑leading precision therapies... ...fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is... ...& Location Hybrid - This position follows... ...IND planning, IND/CTA submission strategy, Phase I/II... ...alignment with clinical, CMC, and non‑clinical...Local areaFlexible hours2 days per week$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...- Takeda seeks an experienced GRA CMC leader to drive regulatory strategies and submissions across global programs. You will lead CMC aspects of registrational submissions, coordinate... ...in complex regulatory contexts. Hybrid work and a Boston, MA location are supported...
- Vertex Pharmaceuticals is seeking an Associate Director, Global Submission Management in Boston to lead a portfolio of global regulatory submissions across development and lifecycle... ...partner with Global Regulatory Strategy, CMC, Labeling, Publishing, and Advertising & Promotion...
$177k - $278.08k
...patients worldwide.Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the... ...regulatory strategy and lead major submissions for high-impact oncology programs.... ...position is currently classified as "hybrid" following Takeda's Hybrid and Remote...Minimum wageTemporary workLocal areaRemote workWorldwide$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory... ...CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify... ...conform to health authority guidelines Lead Regulatory CMC discussions and...Permanent employmentWork at officeWork from home$177k - $278.08k
Job Description Director, Global Regulatory Lead Oncology - responsible for setting global regulatory strategy and leading major submissions for high‑impact oncology programs. About the role... ...Information This position is classified as “hybrid” following Takeda’s Hybrid and...Temporary workLocal areaRemote work- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... ...influence regulatory strategy, prepare and manage submissions, and navigate complex regulatory landscapes. Ideal...
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in... ...candidate will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...
- ...Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface with...
- ...in Boston is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for assigned programs... ...and will manage global regulatory submissions (IND/CTA/NDA/MAA) and interactions... ...cross‑functional teams, with a hybrid work schedule and potential for...Worldwide
- 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...
- 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...
- Moderna is seeking an Associate Director, Global Regulatory, CMC to coordinate regulatory CMC activities across product lifecycles and develop global... ...guide product teams and prepare CMC/Quality regulatory submissions with stakeholders to drive timely approvals. The role...
- Takeda seeks an accomplished GRA CMC Franchise Lead in Boston to independently develop and execute regulatory CMC strategies for TAK-079 across clinical development... ...and Commercial teams to drive major global submissions and ensure regulatory compliance. The role...
- ...DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for... ...and interpret cGMP regulatory guidelines and... ...Expert knowledge of global GMP requirements and... ...proven ability to lead teamsEducation and Experience... ...may be required#LI-hybrid #LI-JS1Pay Range:$18...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week
$174.5k - $274.23k
A leading biopharmaceutical company is seeking a Director Regulatory Site CMC in Boston, MA. The role focuses on regulatory change control and... ...industry, with a strong background in global HA requirements and regulatory strategy. This hybrid position offers a competitive...- Vertex is seeking a Chemistry Manufacturing Controls Manager in Boston to lead regulatory CMC submissions for investigational and commercial products. You will partner with global teams to shape regulatory CMC strategies and coordinate responses with agencies. The role...Remote job
- .... is seeking an experienced Regulatory CMC professional to execute high... ...contributor role collaborates with Global Regulatory Affairs,... ...to ensure timely, complete submissions and alignment with global requirements... ...is based in Boston with a hybrid-work model and may require...
- Jobtailor in Boston is seeking a Senior Regulatory CMC Leader to develop and implement global regulatory CMC strategies for gene therapy programs, lead submission activities, and act as the primary liaison with health authorities such as the FDA and EMA. You will guide...
- Beeline Medicines Corporation is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead the CMC regulatory strategy for monoclonal antibodies and other large molecules. You will drive submissions, interact with FDA/EMA, and align cross‑functional teams across...
- ...Summary:The Associate Director, CMC Quality Compliance and... ...and Skills:Knowledge of regulatory requirements and... ...leanProven ability to lead improvement projects and... ...international travel possible Hybrid-Eligible RolesIn this... ...is a global biotechnology company...Full timeSummer workRemote workFlexible hours2 days per week
- A leading biotechnology company in Boston is seeking a Senior Manager for Regulatory Affairs Operations. In this hybrid role, you will lead global regulatory submissions and collaborate across teams to ensure timely delivery of regulatory documents. The ideal candidate...
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