The Role:Maintain marketing authorisations in Europe through the Centralised, Mutual Recognition and Decentralised Procedures, including preparation and submission of documentation to regulatory agencies. Provide EU...
Maintain marketing authorisations in Europe through the Centralised, Mutual Recognition and Decentralised Procedures, including preparation and submission of documentation to regulatory agencies. Provide EU input to Global regulatory strategies to support LCM activities.
Marketing Authorisation maintenance
- Contribute to Global Regulatory Strategy Documents or create regional regulatory strategies, as necessary, for marketing authorisation LCM applications using EU procedures.
- Coordinate the preparation of marketing authorisation LCM applications to regulatory agencies and responses to agency questions according to required timelines following procedures required under the relevant SOP(s).
- Ensure proposed updates are consistent with current approved dossier information and EU guidelines.
- Coordinate pre-submission meetings with the EMA and other agencies, as necessary.
- Review core dossier (Module 2-5) provided by Global to ensure regulatory requirements are met for the EU region.
- Author M1-3 content for new marketing authorisation applications in line with the regulatory requirements in the business region.
- Ensure submission progress concern is communicated to manager with proposals to mitigate any risks to timelines.
- Coordinate the submission of regulatory applications with Submission Management colleagues.
- Liaise with regulatory authorities to facilitate the prompt review and approval of applications.
- Follow company procedures concerning archiving of correspondence to and from regulatory agencies and recording submission related milestones in the company's regulatory database.
- Develop an appropriate regulatory strategy, risk assessment and probability of regulatory success for assigned projects.
- Scientific Degree.
- Experience of creating regulatory submission strategies and successful submissions.
- Proven ability to manage marketing authorisation applications using European procedures.
- Sound understanding of European regulatory guidelines. Proven experience of preparing and submitting marketing authorisation applications through the Centralised, Mutual Recognition and Decentralised Procedures.
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.