Director/Senior Director, Regulatory Affairs

Director/Senior Director, Regulatory Affairs

Massachusetts - United States

Seeking highly experienced regulatory affairs executives with strong strategic leadership skills and a thorough understanding of global regulatory science in the drug development context. Searching for an Executive to join a small group who comes with a diversified regulatory background since this role requires more than just strategy. This new hire will serve as the department's SME for all global Clinical Studies and global submissions (i.e.: IND and NDA, etc.). Seeking strong global expertise, along with proven leadership skills with a successful track record of developing and executing regulatory strategy while working collaboratively cross-functionally with the team. Prior hands-on experience managing and working with these studies and submissions and have had direct interactions with global health authorities is required. Someone confident and experienced within regulatory to lead development, as well as, plan, execute, interpret and present all regulatory strategy 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.
• IND and NDA experience as well as experience within the 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 regulatory affairs within Oncology therapeutic areas in early and late development.
• Phase II and Phase III experience.
• Registration strategy experience.
• Strong clinically and can write regulatory documents, along with a true regulatory strategist.
• Will be joining the Program Team meetings and strong knowledge of the US FDA and EU 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.
• Solid Tumor 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.

If you meet the qualifications & interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com for more information.