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.
- 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).
- 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
- 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
- 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
Website: ST Recruitment
- Updated: 11th February 2021
- Expires: 11th March 2021