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Sr Regulatory Affairs

Oxford Global Resources ETT is looking to hire for Gilead Sciences a Regulatory Affairs Specialist (maternity leave) who will start in August 2023. As a Regulatory Affairs Technician you will support a top leading research-based bio pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.


  • Review promotional and non-promotional materials in accordance with the company internal promotional guidelines, national regulations and Codes of Practice. Provision of guidance and assistance to Marketing during preparation of promotional material.
  • Cross functional interactions with Business Unit, Medical and other departments if required. Provision of regulatory advice as appropriate
  • Translation of Regulatory documents. Submission and follow-up of regulatory submissions to national authority as well as the amendments to product information as required by acting as a Liaison with Int RA for these activities.
  • Submission of clinical trials amendments and notifications to competent authorities of the clinical trials under his/her responsibility
  • Regulatory Intelligence: Competitors, new regulations or other relevant information
  • Quality topics: Knowledge of applicable regulations. Preparation and update of Quality SOPs, management of complaints and other quality topics.
  • Creation and update of SOPs and associated process documentation as required.


  • Bachelor's degree (or equivalent) in a scientific discipline.
  • Minimum of 2-3 years (in CRO or Pharma) working in Spain regulatory affairs is required
  • Experience in initial CTA is essential
  • Hands-on experience preparing, reviewing, and submitting regulatory documentations


  • Interim/temporary contract maternity leave
  • Ticket Restaurant
  • Medical Insurance
  • Hybrid home-based