The Director / Sr. Director, Regulatory Affairs will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination product.

Skills: regulatory affairs,regulatory submissions,pharmacy,quality systems,strategic thinking,risk management,chemistry,cmc regulatory affairs,regulatory intelligence,manufacturing,project management,cmc.

Job Title: Senior Manager, CMC Regulatory Affairs, Biologics. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans.

The current role is for a Associate Director/Director, Regulatory Affairs to join our team and advance our platform. Associate Director/Director, Regulatory Affairs.

KARL STORZ is a leading medical device company seeking an Associate Regulatory Affairs Specialist - Labeling to join our team. Alternatively, 1 year of experience within KARL STORZ or a degree in Regulatory Affairs.

Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the global development of Avidity compounds.

Minimum 8-10 years of relevant regulatory experience in the biotech and pharmaceutical industry with some supervisory experience; gene editing/gene therapy drug development program experience is strongly preferred.

Job Title: Associate Director, Regulatory Affairs Location: San Diego, CA / Hybrid / Remote Position type: FLSA: Full time Exempt Department: Regulatory and QualityStrive to Bring a Profound Difference to our PatientsAt Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics.

HJF is seeking a Regulatory Affairs Specialist to assist in the compliance of HJF research programs with applicable local, state, and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA.

Kyverna is seeking an experienced and passionate Associate Director, CMC Regulatory Affairs with a strong background in cell and gene therapy, preferably CAR T therapy. Minimum 3-5+ years of CMC Regulatory Affairs experience with direct experience in cell and gene therapy, preferably CAR T therapy.

Under the supervision of the Clinical Research Manager, the Regulatory Affairs Associate will be responsible for coordinating the regulatory and administrative requirements for conducting research and assisting in the management of multi-faceted, complex investigator-initiated treatment protocols and industry-sponsored protocols.

15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.

A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC activities.

OPPORTUNITYMammoth is hiring aDirector/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.

Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.