Regulatory Affairs Officer
A leading pharmaceutical company is advertising a vacancy for a Regulatory Affairs Officer to be based in their office in Belgium. The organisation supports the global life sciences industry across the product development and marketing life cycle by transforming the way organisations capture, monitor, manage, and use information. This position offers the exciting opportunity to work with a company known for being an upstanding partner to life science organisations.
- Providing strategic and operational regulatory support in preparation for the submission and during the review of new Marketing Authorisation.
- Providing input and ensure alignment on submission plans
- Establish submission timelines of Module 1 components.
- Drafting and organising the gathering of the module 1 components.
- Ensuring timely submission to national Agencies.
- Preparing the English Product Information (Summary of Product Characteristics, label, and leaflet) in collaboration with Worldwide Product Labelling.
- Supervising and coordinating the local translation process to ensure timely submission to EMA.
- Ensuring updates to regulatory databases.
- Keeping up to date with EU procedural requirements and legislation.
Skills and Requirements:
- Minimum of 2 years' experience in the pharmaceutical industry.
- An understanding of the end-to-end pharmaceutical lifecycle.
- Knowledge of EU regulatory procedures and development of medicinal products within the Regulatory area in general is preferred.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at +44 207 440 0679 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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