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Their mission: To discover, develop and provide innovative products and services that save and improve lives around the world.
Do you have at least 2 years experience in the pharmaceutical industry and knowledge of EU regulatory procedures?
Don't hesitate to contact me: firstname.lastname@example.org
Support RA activities in the EU region, the non-EU CES countries + Switzerland-close collaboration with the RA Liaison Primary activities include, but are not limited to:
Providing strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements
Liaising with Regional Submission Planner to provide input and ensure alignment on submission plans. Collaborating closely with Regulatory Operations to establish submission timelines
Collaborating closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies
Preparing the English Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Worldwide Product Labelling
For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA
Ensuring updates to regulatory databases
Keep up to date with EU procedural requirements and legislation
Degree in life sciences
Minimum of 2 years experience in the pharmaceutical industry
Knowledge of EU regulatory procedures and development of medicinal products in general is preferred
Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English
Demonstrates the ability to review regulatory documents for accuracy
Understands the end-to-end pharmaceutical lifecycle
what do we offer?
We offer an attractive salary with extra-legal advantages :