Associate Director, Regulatory Affairs

Regeneron

Dublin or Amsterdam

The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in our Dublin or Amsterdam office. The role is positioned at the Associate Director level to enable independent working and leadership in direct interactions with EU Regulatory agencies and with our business partners. This role will be focused on supporting development activities and developing teams in the area of cardiovascular, metabolic and allergic diseases.

What a typical day might look like:

Lead, handle and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team.
Build the representation of Regeneron's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
Assist Development teams in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
Responsible for leading MAA related process and strategy to ensure timely product approvals with competitively differentiated labelling.
Execute clinical trial applications for assigned programs and provide leadership for team members responsible.
As needed, support activity with Business Partners to ensure the EU regulatory strategy meets Regeneron’s business objective.
Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.

This role might be for you if you have:

Advanced degree in a scientific field.
8+ years regulatory experience with a focus on supporting products through clinical development.
Experience of leading and developing staff members.
Consistent record of supporting EU Clinical Trial Applications through approval and study start up.
Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
Experience of bringing a product through EU approval is a distinct advantage.
Ability to negotiate and concisely express clear positions to stakeholders.
Experience of directly working with national regulatory agencies and leading agency meetings face to face.

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