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Senior Regulatory Affairs Associate

Gilead

Prague, Czech Republic

Specific Responsibilities

  • We have an exciting opportunity for an experienced Regulatory Affairs Professional to join us on a 12 month contract in the role of Senior Regulatory Affairs Associate;
  • To be considered for this role you must have:
    • General understanding of regulatory requirements, including ICH requirements and national requirements for assigned territory;
    • Experience in Pharmacovigilance;
    • Excellent organization skills and ability to work on a number of projects with tight timelines is required;
    • Excellent verbal and written communication skills and interpersonal skills are required.
  • Work is performed under the general supervision of more senior Regulatory Affairs professionals.

Essential Duties and Job Functions

Regulatory Affairs

  • Responsible for submissions which require some interactions with others in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures. These may include safety reports, amendments, supplements and other regulatory documents or contributing to preparation of regulatory documents;
  • Provision of regulatory support to Manager Regulatory Affairs ČR & SR, International Regulatory Affairs and local Leadership Team with regards to national regulatory requirements;
  • Deputy of primary contact with national authorities for any regulatory issues regarding the company’s licenses and establishment of good working relationships with national authorities, as required;
  • Review and approval of new or amended product annexes in line with the approved licenses and Gilead’s internal procedures;
  • Review and approval of new or amended packaging materials in line with the approved licenses and Gilead’s internal procedures;
  • Co‑ordinate preparation for distribution and ensure distribution of Dear Healthcare Professional Letters and education materials;
  • Responsible for timely SPC dissemination within Affiliate;
  • Review and approval of promotional materials and representatives training materials in line with national and applicable European legislation, and Gilead internal guidance and procedures;
  • Maintenance of full archive of all local regulatory submissions, communication with health authorities and approvals, including pricing, reimbursement and pre‑vetting of promotional materials, as applicable;
  • Responsible for maintaining electronic regulatory and tracking systems, in a timely manner;
  • May contribute to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments.

Pharmacovigilance

  • He/she will also support PV responsibilities in Czech Republic.

Regulatory Compliance

  • Support for internal company GxP audits and local authority inspections;
  • Support for the business compliance and medical information teams as required.

Knowledge, Experience and Skills

  • Significant relevant industry experience and a BA or BS;
  • Degree in a scientific field is preferred;
  • CP products approval process;
  • GxP legislation knowledge;
  • CTA experience is an advantage;
  • Very good written and spoken English;
  • Experience with work in regulatory systems.

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