For one of our clients, in the region of Brussels, we are looking for an enthusiastic Regulatory Affairs Associate:
- Do you have a scientific backrgound in the Life Sciences?
- Are you fluent in English?
- Do you have a first experience in the Pharmaceutical Industry, preferably in the Regulatory Affairs?
Then, scroll down to take a look at this interesting opportunity!
Under the direction of the Therapeutic Area Lead, Europe, and in close collaboration with the RA Europe (RAA) Associate, depending upon project, you are responsible for supporting the RAA primary activities, both strategic and operational, to help secure completion of regulatory milestones for new products and lifecycle management. This includes the procedural, administrative and planning support for new products, variations submissions and all other regulatory activities in the EU non-EU CES countries, for products approved through the centralized, decentralized/MRP procedures, as well as national procedures linked to MRP/DCP Marketing Authorizations.
•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 (accountable for planning in Regulatory Operations) to provide input and ensure alignment on submission plans. Collaborating closely with Regulatory Operations to establish submission timelines and content of Module 1.
•Drafting of module 1 components and organizing the gathering of the module 1 components.
•Collaborating closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies.
•Preparing the English Product Information (SmPC, label and leaflet) in collaboration with Worldwide Product Labelling (WPL).
•For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA.
•Ensuring updates to regulatory databases as defined in internal policies and procedures.
•Keep up to date with EU procedural requirements and legislation.
•Participate as Subject Matter Expert in relevant workstreams/projects ((global, regional, local). Contribute to continuous process improvement by providing input/generating data in line with applicable procedures, in order to ensure expected quality and compliance standards are met.
•In all daily activities, adhere to the company leadership principles.
Scientific Background - Degree in life sciences.
Minimum of 2 years’ experience in the pharmaceutical industry.
Good knowledge of EU regulatory procedures and development of medicinal products in general is preferred. You understands the end-to-end pharmaceutical lifecycle.
Good organizational skills, proven ability to multi-task, deadline-oriented.
You demonstrate the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
Excellent eye for details and an problem-solving mindset.
Strong written and verbal communication skills in English. Knowledge of French and/or Dutch is a plus
+32 15 21 11 04