Director of Regulatory Compliance

2 weeks ago

United Kingdom EPM Scientific Full time

Director Global Regulatory Affairs
The Director, Global Regulatory Affairs will be responsible for developing, implementing and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives.

Global Regulatory Affairs is expected to:
• Provide high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approvals in international markets, regulatory strategic development plans and risk assessments and lead Health Authority interactions.
• Oversee, contribute to and/or prepare regulatory submissions
• Perform and prepare due diligence assessments that may include risk mitigation strategies
• Prepare regulatory teams for and lead meetings, including face-to-face, with Health Authorities
• Continually build upon and maintain knowledge base of global regulatory landscape, regulations and guidance.
• Manage the development of the ongoing global regulatory strategy
• Postgraduate degree (MS/PhD/PharmD) in Pharmacy, Biological Sciences, or other related discipline
• 15+ years global regulatory affairs experience with increasing leadership in the pharmaceutical/biotechnology industry
•

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