​​Mantell Associates is partnered with a rapidly growing Biologics organisation, who is looking to expand their team with the addition of a Senior Director of Regulatory.

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Senior Director of Regulatory - Responsibilities:

• Develop and implement effective 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 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

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Senior Director of Regulatory - Requirements:

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

• Strong experience within 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

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.