Director of Regulatory Affairs CMC - San Diego

The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor's product lifecycle. · ...

The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor's product lifecycle. This role develops and executes CMC regulatory strategy, ensures compliance with global requ ...

· Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne m ...

· Description · The Director, Regulatory Affairs CMC (RA CMC) will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval) of Viking Therapeutic's candidate projects. The ...

Job Description: · The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across the product lifecycle, with a primary focus on supporting the BLA pathway and advancing other pipeline candidates from dev ...

Job Description: · The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across the product lifecycle, with a primary focus on supporting the BLA pathway and advancing other pipeline candidates from de ...

· The Director, Regulatory Affairs CMC (RA CMC) will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval) of Viking Therapeutic's candidate projects. The Director RA CM ...

Onsite 5 days a week - Candidates must be located in San Diego, CA · The Director, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs. This role serves as the regulatory lead on cross-functional CMC teams and ...

The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor's product lifecycle, · Support the development and execution of CMC regulatory strategy across the product lifecycle (development th ...

Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, · and Controls (CMC) regulatory activities across Capricor's product lifecycle.ResponsibilitiesSupport the development and execution of CMC regulatory strategy... · ...

· Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne m ...

The AD, CMC Regulatory Affairs will lead CMC regulatory strategy and execution in support of global clinical development programs. · Serve as CMC regulatory lead, providing strategic guidance and regulatory oversight. · ...

· About Acadia Pharmaceuticals · Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved t ...

The contractor will assist the Regulatory-CMC Cell Therapy team with projects to support department goals and objectives.Ability to work independently on routine assignments with regular check-ins and to work cooperatively with senior staff providing key assistance on complex ass ...

The Director, Regulatory Affairs CMC (RA CMC) will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval) of Viking Therapeutic's candidate projects. The Director RA CMC w ...

:The Director, Regulatory Affairs CMC (RA CMC) will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval) of Viking Therapeutic's candidate projects. The Director RA CMC ...

+h2>Job summary · seeking an experienced Executive Director of Regulatory Affairs to lead global regulatory strategy for a late-stage development program. · Lead the development and execution of global regulatory strategy for Phase 2 and Phase 3 programs · Serve as the regulatory ...

This position is responsible for leading tech transfer manufacture release and stability of drug substance/drug product analytical activities to support drug development through late-stage commercialization of our lead compound tinlarebant. · This position also assists in qualifi ...

This position is responsible for leading the tech transfer manufacture release and stability of drug substance drug product and analytical activities to support drug development through late-stage commercialization of our lead compound tinlarebant. · ...

The Director of Regulatory CMC will lead strategic regulatory compliance for assigned commercial products and development projects to ensure timely and efficient preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions. · ...