Global Senior Director of RA/QA

Mantell Associates; Greater London; On-site; GBP 110,000 - 120,000; Full time

Job summary

An established industry player in the biotechnology sector is seeking a Global Senior Director of RA/QA to lead their Quality Assurance and Regulatory Affairs team. This role involves developing and implementing effective strategies, mentoring a talented team, and ensuring compliance with global regulations. The ideal candidate will possess strong leadership skills and a proven track record in regulatory processes. This is an exciting opportunity to make a significant impact in a rapidly growing company that values innovation and excellence in the pharmaceutical field.

Qualifications

• Strong experience in Quality Assurance/Regulatory Affairs in Biotech/Pharma.
• Thorough understanding of global regulations (FDA, EMA, ICH).

Responsibilities

• Develop and implement Quality Assurance & Regulatory strategies.
• Manage and mentor a team of regulatory professionals.

Skills

Leadership

Regulatory Affairs

Quality Assurance

Communication Skills

Interpersonal Skills

Education

Bachelor's degree in a scientific or medical field

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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management, Project Management, and Quality Assurance

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing

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