My client is a clinical-stage biotechnology company focused on transforming the lives of patients with severe genetic and orphan diseases. They are seeking an experienced Regulatory Affairs Director to develop and implement regulatory strategies for their Sickle Cell Disease program from Phase 1 through registration. You will be responsible for the preparation, submission, and approval of global applications while leading interactions with regulatory authorities. This is an exciting time to join this fast-paced, energetic, and rapidly growing company!
Responsibilities:
- Design and implement clinical regulatory strategies for multiple rare disease programs including Sickle Cell Disease
- Prepare, coordinate, and manage various regulatory submissions including INDs, orphan drug applications, pediatric investigational plans, and routine maintenance submissions
- Manage the preparation and submission of high-quality regulatory dossiers including development of timelines
- Prepare for and lead interactions with FDA and global regulatory agencies
- Collaborate with regulatory CMC, regulatory operations, and medical writing functions to ensure seamless integration of various components into submissions
- Drive adherence to regulatory guidelines for development of gene therapy products
- Participate in regulatory intelligence activities; review draft regulatory guidelines and monitor trends
- Review all medical affairs/commercial materials to ensure compliance with regulations
- Manage, coach, and mentor two direct reports
Knowledge and Skills:
- BA/BS degree in life sciences with MS/PhD preferred
- A minimum of 7-10 years of regulatory affairs experience in product development for a pharmaceutical or biotech company
- Well-versed in regulatory strategy and regulatory science writing
- Experience as primary regulatory lead for IND and CTA activities. BLA/MAA/NDA experience is a plus
- Demonstrated experience in FDA interactions and FDA meeting preparation. EMA or global experience a plus
- A strong knowledge of FDA and regulations relevant to the development and approval of new therapeutic agents, biologics, and/or vaccines
- Experience in rare diseases, gene or cell therapy a big plus
- Ability to work independently and thrive in a fast-paced environment
- Excellent project management and writing skills, as well as a good understanding of the underlying science
- Prior team management experience a plus
- Excellent communication skills and ability to influence across multiple functions
- Able to handle multiple projects and exercise good judgment in prioritizing tasks