🌍 Regulatory Affairs Manager
We are partnering with a global biotechnology leader that is dedicated to advancing innovative medicines and improving patient outcomes. This organization has a strong pipeline and portfolio across multiple therapeutic areas, and they are seeking a Regulatory Affairs Manager to join their European General Medicine Regulatory team.
💼 About the Role
In this pivotal position, you will ensure the company acquires and maintains the necessary licenses to support clinical trials and market approved medicinal products. You’ll provide regional regulatory expertise, guiding strategies and submissions that shape the future of their portfolio.
Key Responsibilities
* Plan and manage regulatory submissions for clinical trials and marketing applications.
* Implement product-related regulatory strategies in line with national legislation.
* Provide guidance on regional regulatory mechanisms (e.g., Orphan Drug, Fast Track, paediatric plans).
* Support label negotiation activities and contribute to product strategy execution.
* Conduct regulatory research, monitor evolving legislation, and assess competitor labelling.
🎯 Responsibilities
* Scientific degree with proven experience in a regulatory role.
* Strong knowledge of legislation, regulations, and registration procedures for medicinal products.
* Understanding of drug development and the regional regulatory environment.
* Excellent communication skills (oral and written).
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
www.planet-pharma.com
Please click ‘apply’ or contact Finlay Keyworth at Planet Pharma for more information:
E: fleyworth@planet-pharma.co.uk