Associate Director Regulatory Affairs

4 days ago

Uxbridge, United Kingdom Regeneron Full time

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 London (Uxbridge) 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 focussed on supporting development activities and managing teams in the area of infectious disease (including COVID-19).

**JOB DUTIES**

Essential Functions required for the job.
- Where required, lead, manage 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.- Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.- 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.

**JOB REQUIREMENTS**
- Advanced degree in a scientific discipline.
- 8+ years regulatory experience with a focus on supporting products through clinical development.
- Experience of managing and developing staff members desirable.
- Proven track 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 providing EU regulatory strategy for infectious diseases is desirable.
- Experience of monoclonal antibodies is desirable.
- Experience of bringing a product through EU approval is a distinct advantage.
- Ability to negotiate and concisely express clear positions to stakeholders at all levels.
- Experience of directly working with national regulatory agencies and leading agency meetings face to face.
- Excellent written and verbal communication skills.

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