Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

PrimeVigilance

Madrid, Spain

Job Description

  • Prepares and/or manages MA submissions, able to participate on preparation of local administrative documents for submission, QC/compilation and/or ad hoc regulatory advice on submission packages within post-authorisation stage of the medicinal product lifecycle;
  • Reviews and/or provides linguistic input on local Product Information and Mock-ups;
  • Can act as contact point for RA matters for NCA and/or clients;
  • Involved in project management of the network of local contact persons for Regulatory affairs;
  • Manages collection and processing of RA Regulatory Intelligence;
  • Contributes to the proposal of market authorization strategy for clients;
  • Able to deputise for line manager.

Qualifications

  • University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology;
  • Previous industry experience is essential;
  • Knowledge of Regulatory area and applicable legal and other requirements (both local and global) within pharmaceutical industry;
  • Advanced knowledge of English (both written and verbal);
  • Experience with centralised procedures advantageous;
  • Experience with regulatory databases and dossier management software advantageous.

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© EuroJobsites 2022

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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