Senior Director Regulatory Policy
With a focus on the treatment of rare diseases, my client is one of the most innovative biopharma companies world-wide. They currently have five marketed products with over half a billion dollars in revenue and a strong pipeline. They are seeking a Senior Director of Regulatory Policy to influence the heads of various key leaders of the FDA while liaising with internal leadership on the best pathways to approval for various programs. This is an incredible time to join this company as they will be filing four MAA and NDA’s over the next three years. Come join an entrepreneurial environment where you can tangibly impact patient’s lives and also the future of the company!
Responsibilities:
- Serve as a liaison with the FDA on regulatory policy and strategy issues
- Resolve any problems that need to be negotiated various divisions in CDER
- Work with different divisions and oversee different practices to ensure within guidelines
- Review and assess recently published global regulatory legislation and policies impacting development of treatments for rare diseases
- Develop strategic responses to policy and regulatory issues that affect the company’s marketed and pipeline products
- Be the voice of the patient in drug development and PDUFA reauthorization
- Attend FDA meetings, follow up and fulfill commitments
- Lead teams on generation of comments on draft guidance
- Represent the company on trade and patient association calls and meetings, help shape and steer stakeholder discussion based on company regulatory policy, and generate minutes
Knowledge and Skills:
- Minimum MS/JD preferred
- Minimum 10 years’ experience in pharmaceutical or biotech industry Regulatory Affairs including Regulatory Strategy, Regulatory Policy, and/or Regulatory Intelligence
- Must have experience working with CDER or external representation for CDER related programs along with strong FDA relationships
- Must have a solid understanding of FDA regulations and be capable of negotiating with the FDA
- Great communication skills required
- Must be very strong with attention to detail combined with the ability to see the bigger picture and understand business needs
- Strong collaborative skills are a must as this position requires close working relationships with both internal and external stakeholders