Jobid=621881770469363878 (0.0322)
Planet Pharma are currently partnered with a global biopharmaceutical company and we are actively seeking an EU Product Lifecyle Coordinator (Senior Manager) to join the business on a permanent basis in the Netherlands.
Key Responsibilities:
- Lead and coordinate EU/UK/CH regulatory lifecycle activities to ensure timely national registrations, updates, and post‑approval compliance for centrally approved products.
- Drive cross‑functional alignment across Regulatory, PV, Medical, Commercial, and Market Access teams to support seamless product launches and ongoing market maintenance.
- Serve as the primary interface with national competent authorities, managing submissions, queries, and regulatory intelligence across 30+ European markets.
- Oversee product information and labeling (SmPC, PIL, aRMM, artwork), ensuring accurate implementation of centrally approved changes at national level.
- Review and approve promotional and educational materials, ensuring compliance with local codes and regulatory standards.
- Coordinate preparation and dissemination of aRMM materials, collaborating closely with QPPV and PV teams to ensure safety compliance.
- Maintain strong partnerships with affiliates, vendors, and global teams to ensure operational excellence, process consistency, and inspection‑readiness.
- Monitor and communicate regulatory intelligence, assessing impact on the portfolio and advising internal stakeholders on required actions.
Key Requirements:
- 5–10 years of Regulatory Affairs experience within the EU/UK/CH region, with strong exposure to national submissions, lifecycle management, and post‑approval maintenance.
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 Harry Banks at Planet Pharma for more information:
E: hbanks@planet-pharma.co.uk
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