Senior Manager, Small Molecule CMC Compliance - Boston, MA

Responsibilities · Real-time Inspection Readiness. · Develop, manage and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities. · Work directly with CMOs and the Company Manufact ...

We are seeking an experienced CMC Regulatory Lead to provide strategic and operational leadership for all Chemistry, Manufacturing, and Controls (CMC) regulatory activities. · Develop and execute global CMC regulatory strategies to support IND, CTA, NDA/BLA, and lifecycle submiss ...

The Executive Director will provide strategic leadership for global CMC regulatory activities across all stages of drug development and life cycle management. Reporting to the SVP Regulatory and Medical Writing this role serves as a liaison to health authorities driving regulator ...

Director, Regulatory Affairs - CMC (Individual Contributor) · Location: Flexible (U.S. based only, remote or hybrid options available) · Employment Type: Full-time · Summary: · A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regu ...

About the Role · Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. · We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global ...

About the Role · We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. This role is designed for a recognized subject m ...

We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · We seek a recognized subject matter expert in Regulatory Affair ...

We are seeking a highly experienced Senior Vice President, CMC Regulatory Affairs to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · This role is designed for a recognized subject matter exp ...

Antares Therapeutics is seeking an experienced Regulatory Affairs–CMC Strategist (Consultant) to provide senior strategic advisory leadership for global, phase-appropriate CMC regulatory strategies supporting early-stage small molecule product development. · Advanced degree (PhD, ...

We are seeking an experienced and strategic Executive Director to lead global regulatory strategy for pharmaceutical and biotechnology development programs. This role requires cross-functional collaboration with various teams including Technical Operations, Quality, Clinical, and ...

Director, Regulatory Affairs - CMC (Individual Contributor) · Location: Flexible (U.S. based only, remote or hybrid options available) · Employment Type: Full-time · Summary: · A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regu ...

We are seeking an experienced and strategic Senior Director, Regulatory Affairs – CMC to lead global CMC regulatory strategy across a diverse portfolio of small molecule and biologic development programs from early clinical development through commercialization. · This role is a ...

+We are seeking an experienced and motivated Senior Manager / Associate Director, CMC Regulatory Affairs to support global regulatory strategy and execution for clinical and commercial programs. · +Regulatory Strategy & ExecutionRegulatory SubmissionsHealth Authority Interactions ...

SciPro partnered with a late-stage biotech seeking a Director, Regulatory CMC to join their team full-time. · This role leads global regulatory strategies and guides submissions ensuring compliance throughout product lifecycle. · ...

We are a forward-looking R&D organization that unlocks innovation and delivers transformative therapies to patients. · Develops executes oversees regulatory submissions preparation per GRA CMC Product Team CMC strategy.Guide team define drive strategy for CMC regulatory dossier c ...

· Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological ...

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. · Reporting to the Head of Regulatory Affairs CMC, · ...

We are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. · ...

+We are seeking a highly experienced Vice President, Regulatory Affairs, CMC to provide strategic and operational leadership for global CMC regulatory activities across a growing pipeline of innovative therapeutics. · +Define and lead the global CMC regulatory strategy across all ...

Takeda is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. · ...