Director Regulatory Affairs
3 weeks ago
SUMMARY OF POSITION
ORGANIZATION STRUCTURE
The Director, Regulatory Affairs reports into the VP, Regulatory Affairs and is based in Pine Brook, New Jersey. Manages team of 2-5 direct and indirect reports.
RESPONSIBILITIES
QUALIFICATIONS
- Advanced degree in a life science.Minimum of 12 years of pharmaceutical industry experience, at least 10 of those years in Regulatory Affairs. Must have at least 6 years of managerial experience.
- Exhibits excellent written, verbal and negotiation skills. Must be able to effective articulate and negotiate complex project related matters to FDA.
- Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations.
- Strong ability to prioritize, multi-task and work in a very fast paced and dynamic environment.
- Strong critical and logical thinker with ability to analyze problems.
- Highly organized and self-motivated. Demonstrated successes at developing fully functional regulatory teams.
- Able to exercise sound judgement. Demonstrated ability to make sound decisions on regulatory activities, strategies and work outputs.
- Unyielding predisposition to detail, accuracy and clarity.
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