This growing, global biopharmaceutical company is developing and commercializing innovative treatments for patients with rare and orphan diseases. They are seeking a Regulatory Affairs Associate Director or Director who can develop and execute on regulatory strategies for their programs in development and support approved products in the US and Canada. Reporting into the Global Head of Regulatory Affairs, you will work closely with cross-functional teams and interact directly with US health authorities. With multiple approved products and a strong pipeline, this company offers competitive compensation, excellent employee benefits and a patient-focused company culture. Now is an exciting time to join this innovative organization and improve the lives of patients in need! (Note: Although this role is remote, the client prefers candidates in the Eastern Time Zone)
- Provide regulatory guidance and leadership for rare disease programs in development and support approved products in the US and Canada.
- Oversee and lead regulatory submissions including IND, NDA, BLA, orphan drug applications and fast track applications.
- Act as the primary point of contact with FDA and Health Canada and manage agency interactions. Prepare for and participate in meetings with FDA and Health Canada including pre-IND, pre-NDA and Type C meetings.
- Provide leadership and development for direct reports.
- Document the agreed regulatory strategy for North America and key decisions impacting regulatory strategy and submissions.
- Provide regulatory advice to cross functional teams to achieve timely and efficient regulatory submissions while ensuring compliance with applicable regulatory requirements.
- Effectively plan and prioritize regulatory activities in close collaboration with leads from other functional areas. Assure compliance with regulations and with project team timelines and milestones.
- In collaboration with global regulatory colleagues, create and manage submission plans, submission preparation and develop response strategies.
- Develop and author components of regulatory submissions and agency briefing packages as needed.
- Work with other functions and external vendors, in the preparation, review, and completion of documents for regulatory submissions.
- Proactively identify regulatory issues, offer creative solutions and strategies, including risk mitigation strategies. Monitor and anticipate trends that impact the regulatory environment and adapt regulatory strategies in a timely manner.
- Prepare and manage North American Regulatory budget.
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- 8+ years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Direct experience in preparing major drug applications (NDA, BLA, NDS, MAA, etc) required.
- Rare disease experience a plus but not required.
- Regulatory experience with pre-clinical and clinical drug development, along with lifecycle maintenance and compliance.
- Solid working knowledge of FDA, and Health Canada requirements including NDA and post marketing submissions.
- Experience interfacing directly with FDA including meeting preparation. Experience with Health Canada a plus.
- Flexibility with ability to set priorities, work independently, and deliver results in a timely manner and ability to adapt and adjust to new information or changing priorities.
- Proven experience of working collaboratively within global teams and at all levels across an organization.
- Prior management of direct reports highly desired.
- Strong organizational and planning skills, with a proven ability to communicate effectively and efficiently cross functionally and with regulatory agencies.
- Ability to build positive relationships with co-workers of various backgrounds and expertise.
- Outstanding written and verbal communication skills
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.