Global Senior Director of RA/QA

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Mantell Associates is partnered with a rapidly growing CDMO, which is looking to expand their team by hiring a 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.
• Stay at the forefront of new and evolving regulations and guidelines.
• Collaborate with cross-functional teams, including clinical development, medical affairs, and quality assurance, to ensure regulatory compliance and timely product approval.
• Provide an overview of QA/RA policy to stakeholders and staff.
• Monitor and interpret changes in global regulations and communicate their impact on the company\’s products and operations.
• Ensure timely and accurate submission publishing.
• Support M&A activities by engaging with relevant staff.
• Manage a Regulatory Affairs network both externally and internally.

Requirements:

• Bachelor\’s or higher degree in a scientific or medical field.
• Extensive experience in Quality Assurance/Regulatory Affairs within the biotech/pharmaceutical industry, including leadership roles.
• Thorough understanding of global regulations (FDA, EMA, ICH) and their impact on product development and approval processes.
• Strong leadership and management skills, with the ability to mentor and develop a team of regulatory professionals.
• Excellent communication and interpersonal skills for effective interaction with internal and external stakeholders.
• Proven track record in managing 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.

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