To design and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds typically late development, marketed for the WE Area (including...
This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team, they will achieve the desired labeling by developing and executing regional regulatory strategies and managing effective agency interactions.
- To ensure that the company acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products
- Advising the GRT on regional considerations in developing strategy
- Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- May participate as a member of: Global Regulatory
- Team, Global Development Team, Clinical Study Team, Label Working Group and other Regional Teams.
- Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within the company's portfolio in compliance with global filing plans and local regulatory requirements.
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
- Directs the development of the regional product label by collaborating with the Labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions.
- Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
- Regional agency interactions consistent with the Global Regulatory strategy-includes contingency regulatory planning/risk assessment
- 6-8 years' experience in Regulatory, Therapeutic areas, EU market.
- Bachelors or Master's degree in any Life Science
If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 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.