Regulatory Affairs Director

Job Summary

A biotechnology company is looking for a Regulatory Affairs Director.

Responsibilities:

• Provide guidance and support to regulatory affairs' team members and cross-functional teams
• Advise and assist cross-functional teams on regulatory strategies to optimize and expedite the development and maximize the probability of success
• Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation

Qualifications:

• Advanced degree (M.S., Pharm.D., Ph.D.) or B.S. Degree in Biology, Immunology, or related field
• Minimum of 7 years of relevant regulatory affairs experience with an advanced degree or 12 years with a Bachelor's degree, with proven strategic involvement with small molecule drugs and/or biologics development
• Rare Disease experience required; late-stage development for rare diseases is highly desirable
• Experience with a successful US NDA submission experience in rare disease
• Thorough understanding and demonstrated experience with eCTD submission requirements, utilizing document templates, and knowledge of global operational regulations and guidelines