DIRECTOR REGULATORY AFFAIRS

Posting Date: 06.02.2024

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We are looking to recruit a Regulatory Affairs Director for an up-and-coming biotech. This is a full-time, permanent, non-managerial role that can be based remotely from either in the UK or France.

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As a Director Regulatory Affairs, you will be responsible for developing and executing the global regulatory strategy for this company, supporting the development rare disease treatments. You will provide leadership and strategic oversite, advising on new developments in regulatory affairs and ensuring that the latest requirements and standards are met, and program objectives are achieved.

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Responsibilities:

• Responsible for the development and execution of regulatory strategies for biologics in development, maximizing regulatory success. Translates strategy into operational goals and objectives.

• Lead and represent Regulatory Affairs in cross-functional meetings ensuring high quality collaboration and providing guidance on regulatory affairs issues.

• Represents the company in key interactions with the Health Authorities.

• Provide strategic input and guidance on key development of regulatory documents and remains on the forefront of regulatory science to ensure compliance.

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Requirements:

• Solid scientific background, BS, MS, Ph.D., M.D., or PharmD.

• 10+ years of relevant regulatory experience and experience developing and implementing regulatory strategy. Understanding of European & US regulatory principles and their impact.

• Conducted prior negotiations with regulatory authorities.

• Solid understanding of pharmaceutical product development.

• Ability to communicate well and develop strong working relationships with key stakeholders both within and outside the company.

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This is a highly visible role within this company where you will work closely with the senior leadership and be in an optimal position to gain an understanding of the overall company strategies and high-level decision making. The role will appeal to someone who is ready to roll up their sleeves and take the lead on regulatory strategy, gaining a variety of new experiences along the way.

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Get in touch for more information or click on the apply button below to send us your CV or to register your interest.