Director, Regulatory Affairs Cmc

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 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...

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...

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...

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....

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...

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...

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...

Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles IndustryRetail TypePrivately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA interactions and...

Company Overview Tango Therapeutics is a biotechnologycompanydedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...

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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...

Job Title: Associate Director, Global Regulatory AffairsTakeda Development Center Americas, Inc. is seeking an experienced professional to fill the role of Associate Director, Global Regulatory Affairs in Cambridge, MA.Responsibilities:Lead the development of high-level global regulatory strategies for late-stage development projects.Provide global...

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...

Key Responsibilities:As a Vice President, Regulatory Affairs, you will lead the development of innovative global regulatory strategies for Tango Therapeutics. This includes preparing and submitting high-quality sections of briefing documents, INDs, CTAs, and BLAs/MAAs in close collaboration with Nonclinical, CMC, Quality, and Clinical teams. You will also...

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...

Director, Global Regulatory Affairs, Development Strategy This is what you will do: Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.You will be responsible for: Developing and...

Head of Regulatory Affairs About the Company Innovative biotechnology (BioTech) portfolio IndustryBiotechnology TypePrivately Held About the Role The Company is in search of a Head of Regulatory Affairs to take on a pivotal role in leading strategic regulatory decisions for its innovative biotech portfolio. The successful candidate will be a core member of...

Vice President, Regulatory Affairs About the Company Excelling biotechnology (BioTech) company IndustryBiotechnology TypePrivately Held Founded2017 Employees201-500 Categories BiotechnologyB2BHealth CareMedicalTherapeuticsPharmaceuticalsMedicineManufacturingChemical Products Specialties cancerpharmaceutical researchfunctional genomicsdrug discoveryand...