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Regulatory Affairs Officer

Buckinghamshire   •  Competitive  •  Permanent, Full time

Our client is a well-established Biotechnology organisation based in the Buckinghamshire area. Due to continuous growth they are currently seeking to recruit a Regulatory Affairs Officer within their Export department.

Job Role

  • Responsible for international submissions in line with the commercial export strategy & in liaison with the Commercial Team.
  • Liaison with local agents in identified regions for export expansion to ensure the regulatory and commercial aspects are aligned to enable the quickest route for a successful approval.

Qualifications & Training

  • Degree educated – life sciences degree (hons)
  • Minimum 2 years’ experience of working within the Pharmaceutical Regulatory Industry (Regulatory Consultancy, Regulatory Agency or Pharma Company).

Special Experience

  • Experience of licence application submissions via the decentralised and centralised routes within Europe and submissions outside of the EU to global regulatory agencies
  • Working with overseas regulators to co-ordinate the submission processes for export strategies
  • Licensing experience within the Pharmaceutical/Medical industry
  • Understanding & experience of Good Manufacturing Practice/Good

Knowledge & Skills

  • Excellent communication and interpersonal skills
  • Good knowledge of national and international licensing processes & legislation
  • Knowledge of national and international pharmacovigilance legislation
  • Excellent knowledge of medical device certification processes and legislation
  • Excellent organisational skills
  • Ability to work under pressure to meet deadlines/targets
  • Self-motivated
  • Excellent time management
  • Excellent planning and prioritisation skills
  • Ability be work independently with a high level of autonomy and as within a team
  • Personal requirements
  • Self-motivated.
  • Able to deal with conflicts in demand, time constraints and deadlines
  • Ability to manage several projects simultaneously
  • Excellent written and presentation skills.

To apply for this position, candidates must be eligible to live and work in the UK

  • Agency: ST Recruitment
  • Contact: Sam
  • Phone: 01737 241823
  • Reference: BBK16
  • Updated: 11th February 2021
  • Expires: 11th March 2021

ST Recruitment

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