Director, Global Regulatory Affairs

Delaware - United States

*onsite presence required; (relocation assistance provided)

Seeking a highly experienced director with strong strategic leadership skills and a thorough understanding of global regulatory science in the drug development context. Searching for a leader to join a small team within a larger biotech setting. This new hire will serve as the department's SME for all global studies and submissions (i.e.: IND, NDA, BLA, etc.). Seeking strong global expertise, along with proven leadership skills with a successful track record of developing and executing strategy while working collaboratively and cross-functionally with the team. Prior hands-on experience managing and working with these studies and submissions and having had direct interactions with global health authorities is required. Someone confident and experienced regulatory strategist to lead development, as well as, plan, execute and interpret all strategies while working collaboratively and cross-functionally with the team is crucial.

Requirements:

• Advanced degrees in life sciences or in a Scientific discipline or equivalent required with 5+ years of direct experience with 8+ years of drug development experience.
• IND, CTA, NDA, BLA experience as well as experience within Oncology therapeutic area.
• Strong and successful FDA interactions and relations are required. Must be able to handle any FDA requests.
• Very clinically knowledgeable and understand regimens, how drugs are used, how to respond, and clinical questions/requests.
• Strong knowledge of Oncology/Immunology program experience in early and late development.
• Registration strategy experience.
• Strong clinically and can write regulatory documents, along with a true strategist.
• Will be joining the Program Team meetings and strong knowledge of the US FDA, EU, and Japan is required. Understanding EU, EMA issues and questions.
• Experienced in leading the studies and strategies.
• Experience in regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level is required for senior positions.
• Oncology experience
• Successful track record of direct interactions/leading major global health authorities.
• Ability to think strategically and critically and evaluate risks to regulatory activities.
• Ability to work strategically within a complex, business-critical, and high-profile development program.
• Key skills: Strategic thinking & influencing, leadership, initiative, management, communication, negotiation, and presentation skills.