About the Company
Our client, a commercial leader in regenerative medicine, is currently seeking a Regulatory Affairs Manager to join their team. This is a highly-visible role inside a phenomenal work culture, and a chance to work amongst the top-talent in medicine and make a difference in people's life.
The Manager, Regulatory Affairs will be responsible for the regulatory aspects of biotechnology-derived products, including applications submitted to the FDA and other regulatory agencies. This individual will lead the US Regulatory Affairs program for development of multiple cell-based products through the clinical phases and submission of a Biologics Licensing Applications (BLA). Key responsibilities include:
- Writing and submission of IND and BLA applications as well as other submission types for products, with overall responsibility for submissions and writing of Chemistry Manufacturing Controls (CMC) sections.
- Interacting with government agencies and regulatory authorities, as necessary, to facilitate submission review and product approvals
- Planning and participating in meetings with FDA and providing regulatory support for inspections by government and other regulatory authorities.
- Monitoring, identifying and communicating new and relevant changes in applicable regulations, guidance, standards, and other applicable regulatory policies. Providing insight to Regulatory Department and cross-functional teams to ensure compliance with new requirements and promote continuous improvement and current best-practices
- Participating in industry organizations and alliances to influence regulatory policy making and decisions that impact company operations.
- Bachelor’s degree in a science discipline.
- At least 10 years of experience in the life science industry with at least five years of experience in regulatory affairs
- Must have experience successfully submitted regulatory filings to the FDA and other regulatory agencies. Experience working on IND’s and BLA submissions strongly preferred.
- Knowledge of biologic development process and of FDA regulatory requirements for biotechnology products in the U.S. required
- Experience with cell based or tissue products required
If you're interested in this opportunity, please send a copy of your resume to email@example.comHelp immediately