Manager Regulatory Affairs (EU)

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Title
Manager Regulatory Affairs (EU)
Job type
Permanent
Location
Dublin, Ireland or Uxbridge, UK
Specialty
Biotechnology
Salary
Negotiable
Description
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases

Essential Functions required for the job:
  • Assist Development teams and Regulatory management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes.
  • Provide leadership on both late and early-stage clinical development related process and strategy to ensure timely study conduct end to end.
  • Assist clinical teams in study start up and maintenance activities by leading all associated regulatory activities, including but not limited to submissions, addressing agency queries, managing compliance issues.
  • Provide leadership on MAA related process 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).
  • Build the representation of Regeneron's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
  • Further build Regeneron’s regulatory profile in the EU, and serve as a resource for EU knowledge for the global regulatory and development teams.
  • Conduct those activities as deemed necessary under the leadership of the Director of Regulatory Affairs to support program progression.

Job Requirements:
  • Advanced degree in a scientific discipline.
  • 5+ years regulatory experience with a focus on supporting products through clinical development.
  • Experience of life-cycle management of approved products in the centralised procedure a distinct advantage.
  • Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) an advantage.
  • Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
  • 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.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.
Organisation
Regeneron