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Regulatory Affairs Director

2 months ago

Surrey, United Kingdom EPM Scientific Full time

Global Regulatory Affairs Director

**Job Summary**

We are seeking a highly experienced Global Regulatory Affairs Director to join our team at EPM Scientific. As a key member of our organization, you will be responsible for developing and implementing global regulatory strategies to secure and maintain market access for our products.

**Key Responsibilities**

• Provide strategic and operational regulatory direction and mentorship on projects, including general regulatory strategies, regulatory requirements for clinical studies and marketing approvals in international markets, and regulatory strategic development plans and risk assessments.

• Oversee, contribute to, and/or prepare regulatory submissions, including due diligence assessments that may include risk mitigation strategies.

• Prepare regulatory teams for and lead meetings with Health Authorities, including face-to-face interactions.

• Continuously build upon and maintain knowledge of the global regulatory landscape, regulations, and guidance.

• Manage the development of the ongoing global regulatory strategy.

**Requirements**

• Postgraduate degree (MS/PhD/PharmD) in Pharmacy, Biological Sciences, or other related discipline.

• 15+ years of global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry.

• A competitive salary with benefits.

• A real hands-on opportunity to gain a high degree of commercial exposure.

• The chance to work alongside world-leading scientific experts.

• Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.