Senior Regulatory Affairs Officer 591

ProductLife Group is looking for a Senior Regulatory Affairs Officer to work for one of our clients in the Pharmaceutical industry.

About us

Group 10

  • Create regulatory strategies for new products and new markets.
  • Manage the regulatory aspects and licensing of Orphan Drugs within the Intercontinental countries.
  • Obtain new Marketing Authorisations in the Intercontinental markets for designated products/ and designated region and manage the documentation generation process, submission, assessment, approval and product launch regulatory steps.
  • Maintain existing licences (commitments, variations, renewals).
  • Obtain/ generate/ write appropriate documentation necessary to satisfy health authority requirements in the relevant countries
  • Prepare and submit any type of application (Clinical Trial Application, Marketing Authorization Application, variation application, Orphan Drug application, renewal application)
  • Communicate directly with the relevant departments, distributors and local partners on the generation of any regulatory documents.
  • Communicate directly with the MHRA (country of origin) and other health authorities seeking advice, guidance or clarification of legal issues or submission processes in conjunction with line manager.
  • Generate regulatory dossiers in eCTD format.
  • Actively and accurately maintain RA data bases, documentation and procedures to ensure regulatory compliance of products released to market.
  • Continuously identify and make proposals for minor and major improvements related to work place, processes and/or systems

Group 13

  • Similar experience of at least 3 years is required
  • Higherdegree in Life Science, pharmacist is a plus
  • Fluent in English, any other language is a plus
  • Excellent communication skills
  • Able to manage files and skilled with computer utilisation
  • Good time management skills
  • Flexible mindset
  • Self driven person


Senior Regulatory Affairs Officer 591