The Role:Regulatory Strategist EU above Country Reports to EU Regulatory Lead Job focus will support the EU regulatory lead, working with global teams with input...
Regulatory Strategist - EU above Country Reports to EU Regulatory Lead Job focus will support the EU regulatory lead, working with global teams with input into integrated global strategy for product development to enable successful CTAs and to maintain marketing authorisations in a post approval setting.
- Provide input and implement regulatory strategies in agreement with key stake holders for assigned projects/products and in line with research and commercial goals providing an EU regulatory perspective.
- Ensure that all regulatory contributions are delivered to agreed time, cost and quality standards.
- Accountable for working with the EU regulatory lead to advise regulatory sub-team to develop agreed Global Regulatory Strategies and implementation plans for assigned project/s. (Assigned projects may have a regional and/or global focus).
- Partner with Asset Teams and other customer groups to ensure required regulatory contributions (e.g. post-approval licence variations, briefing documents, regulatory strategy plans, CTA, amendments, reports, etc.) meet business needs and are provided to agreed time, cost and quality standards.
- Ensure regulatory strategies achieve the agreed objectives and standards, whilst maximising overall project delivery time and probability of success and facilitating post filing activities.
- Ensure regulatory plans and commitments are monitored, progress/variance communicated to EU regulatory lead and where necessary Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
- Work closely with other colleagues within, and across sites to ensure consistent, and appropriate processes, systems, working practices, shared learning and quality standards.
- Ensure business compliance and implementation of and adherence to Regulatory standards.
- Develop and maintain constructive working relationship with Health Authority contacts.
- Bachelor's degree or equivalent in Life Sciences.
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.