Mantell Associates is partnered with a rapidly growing biotech who is looking to expand their team with the addition of a Senior Director of Regulatory.

Senior Director of Regulatory – Responsibilities:

• Lead and manage the compilation and submission of new investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs).
• Facilitate cross-functional writing of reports, IND sections, protocols, etc. supporting regulatory submissions, as well as review, edit and write documents as needed.
• Prepare and submit INDs, IND amendments, CTAs, marketing applications, and other regulatory submissions, and work closely with functional leaders of the company to produce high quality submissions.
• Provide strategic and tactical input to project teams.
• Assume responsibility for IND/CTA maintenance, including routine / substantial amendments, annual update reports, annual IB updates.
• May coordinate and lead communication with the relevant personnel at the FDA and other Regulatory Authorities.
• Support the preparation and conduct of agency meetings as necessary, including preparation and coordination of meeting requests and briefing packages.
• Manage contract staff and vendors as needed to support regulatory activities, including oversight.
• Coordinate with regulatory vendors as needed to generate documents suitable for regulatory submissions.
• Liaise with cross-functional team members to ensure consistent messaging related to development activities (e.g., ensure response to questions are consistent to EC’s /IRB’s and Regulatory Authorities.)
• Identify regulatory risks and provide mitigation suggestions leading to informed decision making.
• Other duties as assigned.

Senior Director of Regulatory – Requirements:

• Bachelor’s degree required. Advanced degree preferred.
• RAC certification from the Regulatory Affairs Professionals Society a plus.
• Minimum of 10 years in the pharmaceutical / biotech industry with a minimum of 7 years’ experience in Regulatory Affairs in the pharmaceutical/biotech industry.
• Experience preparing Health Authority packages including meeting briefing packages for FDA and/or EU meetings.
• Regulatory experience with respiratory/ inhaled products is preferred.
• Good understanding of global regulatory environment.
• Excellent written and verbal communication skills.
• Ability to manage multiple tasks with autonomy.
• Comfortable in a fast-paced environment

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.

Tagged as: Regulatory