Regulatory Affairs CMC Associate

Job Description Job Description Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of...

Job DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...

Job DescriptionJob DescriptionFoster City, CAContract Duration: 12-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role)Contractor must meet the company site requirements for the COVID Vaccination PRIOR to starting roleResponsible for the preparation of Drug...

Ensuring the projects they are responsible for have a cohesive regulatory strategy that is integrated into Pharmaceutical Development & Manufacturing (PDM) Project teams. The role will report directly to Head of CMC Regulatory Affairs Small Molecul Regulatory Affairs, Director, Regulatory, Leadership, Product Development, Business Services, Strategy

**General** **Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the...

My client is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases. They are currently seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CMC aspects...

Job Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...

Reporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. **Responsibilities** - Prepare and/or coordinate and comply routine regulatory submissions and other...

MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies...

My client is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases. They are currently seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CMC aspects...

This clinical-stage biotechnology company is developing potentially curative therapies for heart disease. They are seeking a Regulatory CMC Executive Director or Senior Director to lead CMC Regulatory strategies and execution for their portfolio of programs. Reporting into the SVP of Regulatory, you will lead CMC submissions and work directly with health...

About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...

Job Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...

We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

Director of Regulatory Affairs San Jose, CA REF DESCRIPTION The position is independently responsible for development of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. You will be responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for investigational drug-device combination...

Responsibilities and Duties:Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictionsOversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissionsConduct regulatory review of submission documentsCoordinate with external publishing...

We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...