Regulatory CMC Associate Director

Associate Director, Regulatory CMC (Boston) Job Description The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages the interactions with Health Authorities for CMC topics....

Job Description:The Chemistry Manufacturing Controls Director is responsible for executing global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics.Key Responsibilities:Leads the preparation and review of...

This is what you will do: Position Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio.You will be responsible for: Job Duties and Responsibilities Provide CMC support and...

Position Summary This position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity...

Senior Director, Regulatory CMC PepGen is at an exciting time in our development. This role is for a motivated and team-oriented individual who flourishes in an environment where they can help lead and shape our future.As an integrated member of the PepGen Team, you will lead, develop, and implement robust regulatory CMC strategies and provide advice on the...

Job SummaryThis is a key leadership role in our Global Regulatory Affairs team, responsible for providing strategic guidance and oversight on CMC regulatory matters for our clinical and commercial product portfolio.Key ResponsibilitiesProvide CMC regulatory support and advice for all internal activities related to manufacturing, development, control, and...

Job Title: Head of Regulatory Affairs-CMCJob Summary:Ironwood Pharmaceuticals seeks a seasoned Regulatory Affairs expert to lead our CMC function, ensuring compliance with global health authority regulations and guidelines. As Head of Regulatory Affairs-CMC, you will develop and execute a strategic regulatory plan to support product development and...

Job Title: Director, Regulatory Affairs CMCJob Summary:This is a key leadership role for the development of the In Vivo franchise at CRISPR. The successful candidate will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC lead for these programs, you will have the opportunity to devise...

Senior Director of CMC OperationsJobleads-Us is partnering with a biotech company seeking a Senior Director of CMC Operations to lead CMC activities in recombinant protein therapy from academic development to clinical manufacturing. As a pivotal hire, you will work closely with the CEO and company advisors to develop and execute phase-appropriate CMC...

Sr. Director, CMC (Protein)Location: 3-day On-site Boston, MA HireMinds is partnering with a new biotech seeking your expertise to help in their mission to get to IND in 2025 for rare disease patients in dire need. In this role you'll be a pivotal hire working closely with the CEO and company advisors. As the Senior Director of CMC, you will lead CMC...

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or...

Director of Quality CMC Development - East Coast based remote This role offers the flexibility to work remotely from locations within the U.S/Canada, with a preference for Eastern Time Zone working hours to collaborate with EU teams.Travelis required.Position Overview: Cpl Life Sciences is looking for a Director of Quality CMC Development (Product...

Job Summary:Jobleads-Us is seeking a skilled Senior Director Regulatory Strategy Lead CMC Device and Combination Products to join our team. In this role, you will be responsible for developing and implementing innovative pure device and combination product regulatory strategies. You will lead global regulatory submissions, work closely with cross-functional...

Job Title: Director of Quality CMC DevelopmentThis role offers the flexibility to work remotely from locations within the U.S/Canada, with a preference for Eastern Time Zone working hours to collaborate with EU teams.Job Summary:Jobleads-Us is seeking a Director of Quality CMC Development to lead and oversee the formulation and process development of animal...

Job Title: Associate Director/Director, Regulatory AffairsScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Our team is seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of...

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Associate Director, CMC Strategic OperationsJob Description General Summary: In this role you will have the responsibility to advance multiple cross-functional strategic initiatives within the Pharmaceutical Sciences organization. By partnering closely with Senior leaders both within and outside of the department, you will propose strategic direction, gain...

Regulatory Affairs Director or Senior DirectorThis clinical-stage company is advancing innovative therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and execute on global regulatory strategies for an early-stage Rare Disease program. In this role, you will work closely...

About the Role:Takeda is a leading pharmaceutical company that aims to deliver transformative therapies to patients worldwide. We are seeking a highly experienced Senior Director to lead our Pharmaceutical Development Portfolio as part of our Regulatory Affairs team.Key Responsibilities:The successful candidate will establish collaboration with Global CMC...

Job Title: Vice President, Regulatory AffairsCompany Overview: Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Job Summary: We are seeking a highly experienced Vice President, Regulatory Affairs to lead our regulatory affairs team...