Lead Consultant, Regulatory CMC (Biologics)

Lead Consultant, Regulatory CMC, Biologics

100% Remote - United States

Seeking an experienced Lead CMC Regulatory professional with strong strategic leadership skills and a thorough understanding of global regulatory science in the drug development context. This new hire will serve as the department's SME for all biological studies and submissions. 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 leading and developing regulatory development strategies and submissions. You will work closely with the clients and help guide reg activities covering from pre-IND all the way through to commercialization, and post-approval deliverables.

Requirements:

• Bachelor's degree in life sciences or in a Scientific discipline or equivalent required with 10 years of CMC Regulatory in a biopharmaceutical setting (Advanced degree preferred).
• Strong knowledge of current regulatory guidance, GxPs, and industry developments.
• Strong and successful FDA interactions and relations are required. Must be able to handle any FDA requests.
• Experienced in leading CMC Regulatory strategic activities across all phases of the drug development.
• Very clinically knowledgeable and understand regimens, how drugs are used, how to respond, and clinical questions/requests.
• Will be joining the Program Team meetings and strong knowledge of the US FDA, and EU. Understanding EU, and EMA issues and questions.
• Experienced in the Biological product space.
• Experienced in leading the studies and strategies.
• 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 interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.