Global Senior Director of RA/QA

JR United Kingdom; Slough; On-site; GBP 90,000 - 140,000; Full time

Job summary

A leading CDMO is seeking a Global Senior Director of RA/QA to develop regulatory strategies and manage a team of professionals. The successful candidate will lead compliance efforts and engage with stakeholders to ensure timely product approvals within a growing organization. Expertise in global regulations and leadership in Biotech is essential.

Qualifications

• Strong experience in Quality Assurance/Regulatory Affairs in Biotech/Pharmaceutical sector.
• Thorough understanding of global regulations (FDA, EMA, ICH).
• Proven track record of Global Regulatory Processes.

Responsibilities

• Develop and implement effective Quality Assurance & Regulatory strategies.
• Manage and mentor a team of regulatory professionals.
• Collaborate with cross-functional teams to ensure regulatory compliance.

Skills

Leadership

Regulatory Compliance

Quality Assurance

Communication

Stakeholder Engagement

Education

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

Job description

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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.