Senior Director, Regulatory Affairs CMC

3 weeks ago


Philadelphia, United States CareerBuilder Full time

Our client, a top pharmaceutical company with an innovative approach to medicine and patient care, is seeking a highly experienced Senior Director for their Regulatory Affairs CMC - Biologics team. The ideal candidate will have extensive experience working within large pharma organizations and possess exceptional leadership skills.

Responsibilities:
-Leading cross-functional teams across various departments to ensure regulatory compliance throughout all stages of product development - from early pre-clinical research through commercialization.
- Developing global regulatory CMC strategies
- Providing strategic guidance on drug development programs
- Ensuring successful IND/BLA filings globally
- Leading negotiations with health authorities

Qualifications:
-At least 10 years relevant pharmaceutical industry experience
-Minimum 5+ years as senior management role directing others; demonstrated success managing complex projects or initiatives that span multiple functions/business units; proven ability developing junior staff members into future leaders
-Masters Degree in a scientific discipline preferred

If you are interested in learning more, please apply here.

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