Associate Director Regulatory Affairs UK and Ireland

☞ Seagen

View: 191

Update day: 26-03-2024

Location: Zug Zug ZG

Category: Legal / Contracts

Industry: Research Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Description

Position at Seagen

Summary

The Associate Director, Regulatory Affairs UK/Ireland, provides regulatory leadership for the UK/Ireland region’s business in support of the marketed products and development programs at Seagen. This includes responsibility for developing regulatory strategies, planning, managing and executing regulatory activities for drug products in the region, in accordance with the goals of the company, and applicable regulations, standards, established procedures and planned objectives. The Associate Director Regulatory Affairs UK/Ireland may have management and development responsibilities for direct reports.

Principal Responsibilities
  • Formulate UK regulatory strategy, in collaboration with the European Regional Leads and Global Regulatory Teams (GRTs), to shape optimal global regulatory strategies for established and development products
  • Provide strategic input for all UK/Ireland Regulatory Affairs matters, including the seeking of Scientific Advice, maintenance of the existing MA, planning and execution of new MAAs, CTAs, and other relevant regulatory procedures, in collaboration with the European Regional Lead.
  • Serve as the primary point-of-contact for MHRA and HPRA for the company’s regulatory applications in the UK and Ireland.
  • Collaborate with European Regional Lead in managing emerging issues (e.g. new safety or quality finding) and associated risk communications to stakeholders in the UK and Ireland.
  • Develop and maintain highly collaborative relationship with the global and regional teams.
  • In partnership with other regulatory staff, maintain and expand current knowledge of UK/Irish regulatory requirements and precedents, interpret changes, that may affect the clinical development and commercialization of company products in those countries, analyse gaps, conduct impact assessment, and participate/lead implementation of improvements into systems/processes.
  • Provide trainings/briefings on specific UK/Irish regulatory topics to project teams and other stakeholders to ensure effective product development, registration, and compliance with the countries’ regulatory requirements
  • Performs other duties as required

Required Qualifications
  • PharmD, PhD, Masters or Bachelors degree in life sciences
  • Minimum of 8 years of Regulatory experience, with at least 5 years in a similar UK and Ireland-based strategic role
  • Expert knowledge of UK and Irish regulatory requirements and environment
  • Direct experience of regulatory submissions and agency interactions in the UK and Ireland
  • Experience of overseeing vendor services and cross-functional collaborations
  • Thorough knowledge of drug development and life-cycle maintenance processes
  • Familiarity with FDA IND/NDA/BLA and European regulatory procedures
  • Fluent in English (spoken and written)

Preferred Qualifications
  • Line management experience
  • Regulatory project management experience
As a leading employer in our industry, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. To learn more about Seagen, please visit.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment.
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Deadline: 10-05-2024

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