Mantell Associates
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.