Sr Director, Regulatory Affairs

Sr Director, Regulatory Affairs

Gilead

Munich, Germany

Context to the position

Currently, Gilead Germany are looking for a new Regulatory Affairs Head who will be based in the German affiliate located in Martinsried/Munich and will lead and manage defined regulatory affairs and associated activities. He/she will be responsible for management of a team of in total 9 regulatory affairs professionals and will be part of leadership team.

Primary Responsibilities

Registration

  • Primary contact with national authorities for regulatory issues for Gilead’s products.
  • Liaison with Gilead International Regulatory Affairs regarding submissions relating to Gilead’s products.
  • Submission and follow-up of all regulatory submissions to national authority, including submission of Clinical Trial applications, amendments, notification, etc and new or amended SmPC’s to national compendia, variations, etc.
  • Obtain and maintain necessary regulatory-associated licenses with national agencies required for Gilead’s business.
  • Obtaining, providing and interpreting national regulatory intelligence with International Regulatory Affairs; will require interaction (networking) with Health Authorities and may require participation with national committees.

Regulatory Compliance

  • As deputy Commissioner of the graduated plan (Stufenplanbeauftragter) according to the German Drug Act (AMG) Section 63a ensures compliance with all safety relevant regulations applicable to this position.
  • Ensure compliance within the company with all applicable (pharmaceutical) legislation (e.g. GMP/GDP guidance, EFPIA/FSA codex) relevant to the position on national and international level.
  • Coordination of local authority inspections or Gilead internal audits on GxP.
  • Preparation and maintenance of required and relevant local SOPs and associated process documents required internally and externally.
  • Dissemination of new or amended product information to the local company employees.
  • Coordination of record retention as required for regulatory affairs.
  • Review and approval of new or amended packaging components in line with the products’ licenses for the products marketed locally.
  • Support compliance with of GDP requirements if required.
  • Represent, as appropriate, Gilead Germany with national authorities on regulatory compliance.

Commercial Compliance

  • As Informationsbeauftragter (national qualified person for scientific service) according to the German Drug Act (AMG) Section 74a ensures compliance with all regulations applicable to this position, e.g. HWG, AMG.
  • Support as appropriate the maintenance and operation of Gilead Business Conduct.
  • Contribute to and support the review and approval of promotional and non-promotional materials in accordance to Gilead internal promotion guidelines, national legislation and Code of Practice.
  • Provision of guidance and assistance to Commercial function during preparation of promotional materials.
  • Provide Regulatory Affairs review and approval of any other activity specified under the local Code of Practice (interactions with HCPs, including consultancy/speaker contracts, grants and donations; advisory boards, non-HCP meetings).

Quality Assurance

  • Act as responsible person for Quality Assurance.
  • Provision of compliance with applicable laws, regulations and internal procedures.
  • Represent, as appropriate, Gilead Germany with national authorities on quality matters.

General Management and Administration

  • Line management of Regulatory Affairs team and control of the budget for this department.
  • Support and contribute to agreed cross-functional and Affiliate leadership matters.
  • Perform required reporting obligations, internally and externally.
  • Support individuals, teams, functions and external parties in the performance of their duties on behalf of the German Affiliate.
  • Support Regulatory Affairs input to crisis and incident management and business continuity planning, as required.
  • Represent regulatory affairs and Gilead Germany with external parties, as appropriate and when required.

Professional Experience/Qualifications

  • Extensive relevant industry experience in regulatory affairs and understanding of current trends in local and regional requirements.
  • Experience in developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.
  • Demonstrates strong leadership skills with a sphere of influence externally, cross-functionally and within the RA function.
  • Experience of and excellence in providing leadership and managing an experienced team.
  • Degree in Pharmaceutical Sciences or equivalent discipline, An advanced degree is desirable.
  • In-depth knowledge of national and international regulatory requirements for medicinal products.
  • Extensive knowledge and experience in regulatory systems.
  • Excellent written and verbal German and English communication skills.
  • Excellent interpersonal skills.
  • Ability to plan schedules and arrange own activities timely and efficiently.
  • Excellent organization skills and ability to work on a number of projects with tight deadlines.
  • Is recognized as a knowledgeable resource for regulatory advice for other functions and teams.
  • Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and with external parties (national authorities, trade associations, professional bodies, etc.).

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© EuroJobsites 2019

EuroJobsites is a UK 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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