Associate Director, Regulatory Cmc

Job Title: Regulatory CMC Associate DirectorJob Summary: We are seeking a highly skilled Regulatory CMC Associate Director to join our team at Vertex. The successful candidate will be responsible for executing global regulatory CMC strategies for investigational and marketed products.Key Responsibilities:Lead the preparation and review of CMC sections of...

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 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...

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...

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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...

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...

Associate Director, Quality Control Reporting to the Senior Director, Analytical Development & Quality Control (QC), the Associate Director of Quality Control will be acting as QC lead, responsible for leading and managing the QC activities of PepGen's pipeline. In addition, this position will be required to actively support the preparation of regulatory...

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.How you will contribute:OBJECTIVES:...

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...

This 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 with cross-functional teams and Health...

Job Details Position Overview: We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. You will play a key role in vendor...

Associate Director/Director, Development Program Management Boston, MA, USA Req #303 Tuesday, August 13, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with...

Associate Director, Regulatory Submission Management Job Description The Associate Director, Regulatory Submission Management is responsible for the planning, managing, and tracking of the regulatory portfolio of submissions across a number of assigned programs. This role will be responsible for driving comprehensive plans and reports that would include all...

Job Description About the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients...