Regulatory Affairs Manager
12 month contract
EU Oncology - Global biopharmaceutical company
Competitive pay rateDescription
The Regulatory Affairs Manager will support one or more products from a regional regulatory perspective.
The purpose of this role is to ensure that our client acquires and maintains
all the required approvals in order to support clinical trials
for investigational medicinal products as well as to market approved medicinal products
and to ensure timely regulatory compliance with above approvals.Key responsibilities include:
- * Under general supervision, planning and managing regulatory submissions (e.g. clinical trial and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements.
* Under general supervision, developing and/or implementing innovative and compelling regulatory strategies designed to enable patient access, following regulatory affairs processes and activity planning in accordance with national legislation and regional regulatory requirements.
* Under general supervision, participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
* Providing regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans)
Knowledge and Skills:
- Relevant experience with regulatory activities in the EU region including clinical trials (CTAs) and registration procedures (MAs, post approval changes, extensions and renewals).
* Experience with EU and national legislation and regulations relating to medicinal products
- 4+ years of pharmaceutical Regulatory Affairs experience concerning EU Clinical Trial Applications