Director, Regulatory Affairs Europe

Director, Regulatory Affairs Europe

Incyte

Morges, Switzerland

Summary

The Director leads regulatory objectives, advice and strategy in alignment with department and corporate goals. He/she will guide multi-functional teams to ensure that regulatory requirements for the assigned products are achieved. He/she will act as the official liaison with European Regulatory Agencies and will lead preparation and conduct of meetings with European Regulatory Agencies.

He/she plans and leads regulatory document preparation for regulatory submissions in Europe and in International geographies including CTAs, MAAs, Variations, Orphan applications, PIPs. He/she keeps abreast of evolving regulatory procedures and practices.

Duties and Responsibilities

  • The Director will be responsible for ensuring that Incyte is developing and executing optimal regulatory strategies for Europe and International geographies, and for preparing and supporting interactions with regulatory authorities appropriately.
  • Develop and lead globally aligned regulatory strategies for novel small molecule and biologics. Activities include Scientific Advice, Orphan Drug Designations, pediatric plans, registration procedures to optimize successful regulatory review and approval
  • Review and interpret regulatory correspondences for global project teams
  • Provide regulatory guidance and support to inter-departmental project teams and interact proactively with other Incyte functions, contract research organizations, partner companies, and health authorities
  • Prepare, support and lead Incyte functions for interactions with regulatory authorities and for regulatory submissions
  • Work with global regulatory team to agree contents for timely submissions to Health Authorities
  • Plan and lead the preparation, review, and approval of compliant regulatory documents for European and International CTA and MAA submissions throughout the product lifecycle
  • Ensure that data provided are presented clearly and succinctly to optimize the regulatory review and approval process
  • Lead and coordinate the preparation of responses to questions and inquiries from Health Authorities. Prepare and submit CTA amendments, DSUR and MA Renewal in accordance with regulatory submission schedules and regulations.
  • Work with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format
  • Ensure accurate retention in the archival system of all regulatory submissions and contacts with health authorities
  • Lead and support regulatory activities with affiliates and consultants including regulatory review of promotional materials by specific country RA affiliate/consultant
  • Contribute to improvements in department operating procedures
  • Remain current with evolving regulatory procedures and practices, and provide guidance to Incyte project teams
  • Contribute positively to a strong culture of business integrity and ethics
  • Act within compliance and legal requirements as well as within company guidelines

Requirements

  • BS degree, preferably in a scientific discipline with a minimum of 10 years pharmaceutical/biotechnology experience and with a minimum of 8 years regulatory experience, preferably including one full submission or line extension through authorization
  • Experience in leadership (cross-functional or functional)
  • Experience in interactions with regulatory agencies. Experience with clinical trial applications
  • Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability
  • Familiarity working with electronic document management and submission platforms is desired
  • Experience in immunology, oncology and orphan products

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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