BioTalent are proud to be supporting a long-term client, a Global Biopharmaceutical company developing innovative oncology products, in their search for a Regulatory Affairs Lead for the UK and Ireland.

The role will be responsible for the following:

• Leadership of the UK Regulatory team
• Strategy for assigned marketed products and development projects in Ireland and the UK
• Act as the regulatory liaison and primary contact person for MHRA and HPRA
• Develop regulatory strategies and advice and provide clear guidance and information to internal and external stakeholders.
• Advise on national submissions and evaluate the content and adequacy of regulatory submissions, identify deficiencies requiring further resolution.

Requirements:

• At least 8 years of relevant Regulatory Affairs experience, including both regulatory drug development and post-approval activities
• A relevant scientific/life science degree
• 2 years of leadership experience