Global Senior Director of RA/QA - #1672450

Mantell Associates is partnered with a rapidly growing CDMO, who is looking to expand their team with the addition of a Global Senior Director of RA/QA.

Global Senior Director of RA/QA - Responsibilities:

• Develop and implement effective Quality Assurance & 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 QA/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

Global Senior Director of RA/QA - Requirements:

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


• Strong experience within Quality Assurance/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 44 (0)20 3854 7700.