The Role:To ensure that the company's EU procedure marketing authorisations are appropriately maintained and renewed, thus facilitating supply of products, compliant with those marketing authorisations,...
To ensure that the company's EU procedure marketing authorisations are appropriately maintained and renewed, thus facilitating supply of products, compliant with those marketing authorisations, to patients. Provide support as needed to assist European Country Regulatory Leads to maintain and renew the company's national marketing authorisations within the European region.
Marketing Authorisation Maintenance
- Contribute to Global Regulatory Strategy Documents or create regional regulatory strategies as necessary, concerning proposed changes to European marketing authorisations in support of business needs.
- Ensure any proposed updated CTD sections are consistent with the currently approved CTD section (incorporating changes related to proposed variation only) and that they are in line with appropriate current EU guidance on the contents of those CTD sections.
- Coordinate the preparation of lifecycle (post-approval) submissions and subsequent responses to agency questions via Submission Management, according to required timelines and following the procedures described in the relevant SOP(s).
- Liaise with regulatory authorities as required 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.
- Assist in the administration of companies Change Management Procedure, acting as change owner where appropriate.
Periodic Safety Reports
- Coordinate regulatory actions relating to the preparation/review of Periodic Safety Reports as required under the relevant SOP(s).
- Coordinate regulatory actions required upon launch or cessation of marketing as required under the relevant SOP(s)
- Scientific Degree.
- Experience of creating regulatory submission strategies and successful submissions.
- Proven ability to manage complex lifecycle submissions using European procedures.
- Experience preparing and submitting marketing authorisation notifications, variations and renewals.
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.