Senior Director of Regulatory - Biologics

Posted 08 December 2023
LocationUnited States of America
Discipline Large Molecule
Contact NameNikhil Akkoo

Job description

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

Senior Director of Regulatory - Responsibilities:

  • Develop and implement effective Regulatory strategies by maintaining Policy and Intelligence

  • Manage and mentor a team of regulatory professionals, providing guidance and leadership to ensure adherence to global regulations and internal policies

  • Be at the forefront of new and developing regulations and guidelines

  • Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance and timely product approval

  • Responsible for providing an overview of RA Policy to stakeholders and staff

  • Monitor and interpret changes in global regulations and communicate the impact on the company's products and operations

  • Ensure submission publishing is well executed and on time

  • Engage and support all relevant staff to support M&A activities

  • Proactively manage a Regulatory Affairs network externally and internally

Senior Director of Regulatory - Requirements:

  • Bachelor's or advanced degree in a scientific or medical field

  • Strong experience within Regulatory Affairs in the Biotech / Pharmaceutical space, including leadership experience

  • Thorough understanding of global regulations (FDA, EMA, ICH) and their impact on product development and approval

  • Strong leadership and management skills, with the ability to mentor and develop a team of regulatory professionals

  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders

  • Proven track record of Global Regulatory Processes

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.