Director/Senior Director Regulatory Affairs
Reporting to the Chief Medical Officer, you will be responsible for developing and implementing regulatory strategies, and coordinating all aspects of regulatory submissions. My client is a clinical-stage company based in the heart of Research Triangle Park, NC which is developing innovative oncology programs. The ideal professional has the drive to want to make a difference in patients’ lives and is able to work in a small, fast paced, and science driven culture.
Responsibilities:
- Develop and lead clinical regulatory strategies with executive management, reviewing and providing comments on protocols and development plans.
- Lead all efforts with regulatory filings
- Be the primary lead working with global regulatory agencies
- Be the face of the Regulatory Affairs team for the company
- Develop and implement regulatory strategies for investigational, and ultimately, commercial drug products
- Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic
Knowledge and Skills:
- Minimum BS/BA in scientific discipline required, advanced degree (MS, Pharm.D or Ph.D preferred
- Minimum of 10 years industry experience with 5 years spent within oncology
- Must have a strong knowledge of eCTD elements
- Previous experience leading submissions in a regulatory capacity
- Experience with drug development, FDA, EMA, and ICH guidelines
- Must be a self-starter, takes initiative and has an ability to wear multiple hats in a small, collaborative biotech environment
- Companion diagnostics experience preferred but not required
- Some CMC experience is a plus