Regulatory Affairs Specialist Medical Device North West £CompetitiveSRG are currently recruiting for a Regulatory Affairs Specialist to join a Global Medical Device company in the...
Performance of pre and post approval regulatory activities to ensure compliance with the Falsified Medicines Directive.
- Preparation and submission of MA variations, Article 61(3) applications and Change of Ownership applications.
- Process and have clear communication of regulatory approvals to internal and external stakeholders.
- Create, review and approve artwork texts and mock-ups.
- To plan and track manufacturing site readiness and associated regulatory activities in collaboration with local FMD project manager.
- Generation of status update reports concerning local FMD readiness.
- Maintenance of regulatory archives and version controlling.
- Work in accordance with Global and local Working Instructions and SOPs.
- Carry out other activities which contribute to the effective performance of the Regulatory Affairs Department.
- BSc in Life Sciences
- Experience in Regulatory Affairs within a Generic or Pharma business.
- Ability to be flexible and multi-task within a fast-paced environment.
- Experience in project management.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.