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Regulatory Affairs Officer – Oost-Vlaanderen

Introduction

Our client is looking for a Regulatory Affairs Officer. The RAO ensures that medicinal products for both human and veterinary use, as well as non-medicinal products such as cosmetics, food supplements, medical devices, and animal feed, comply with relevant licensing, marketing, and legal requirements.

Function

1. Portfolio

  • Manage regulatory activities for the licensing of food supplements (including new ingredients), cosmetics, medical devices, animal feed and homeopathic medicines for our client and specific contract manufacturing customers.
  • Involves pro-actively within the development of new products.
  • Prepare and submit notification/registration/authorisation dossiers.
  • Ensure that the portfolio or new products are manufactured and distributed in compliance with the approved authorisation, regulatory guidelines and legislation.
  • Pricing medicine portfolio.

2. Customers

  • Provide regulatory input and active support in new product innovations and work closely together with the product innovation manager on the evaluation of new formulas and to find the most suitable health claims for new products.
  • Reports regularly on the status of the products or projects and provide response to questions of internal (management, other departments) and external customers (headquarters, regulatory authorities) on the client or Contract Manufacturing portfolio.
  • Inform proactively and timely internal and external customers on the status of regulatory dossiers or on any regulatory/scientific change which might have impact on the compliance of the portfolio to the applicable legislation.
  • Updating system (server, portfolio, …) in line with most recent regulatory status of products.
  • Support our customers with the submission of technical dossiers when needed and with certificates upon request (allergene declarations, certificate of conformity, …).

3. Learning: keep informed on the current scientific and legal standards

  • Collecting, collating and evaluating information in a variety of formats.
  • Proactive follow-up and monitoring of the current legal and regulatory requirements concerning registration of products (medicines, food supplements, cosmetics, medical devices, animal feed, …) and initiate implementation of relevant changes.
  • Share proactively information on new regulations, guidelines or other relevant matters concerning our products and projects.

4. Provide support to the Regulatory Affairs Manager

  • Reporting of activities, including providing input for monthly internal reporting.
  • Budget process: provides the requested input on planning of expenses and dossiers.
  • Participate in the approval process of medical marketing materials for non-medicinal products and medicinal products, by checking if all publications and promotional materials are compliant with the SmPC, the leaflets and the authorized claims.
  • Internal and external questions (e. g. update notifications, …).
  • Providing support and guidance on regulatory strategies.
  • Preparation of meetings and assisting during the meetings when necessary (internal and external).

Requirements

QUALIFICATIONS / KNOWLEDGE / EXPERIENCE

Basic Education and technical capacities

  • Minimum a bachelor’s degree in a life science discipline (such as pharmacy, chemistry, biochemistry, biotechnology, chemical or biomedical sciences).
  • Appropriate computer skills (Word, Excel, PowerPoint, Outlook, Adobe Acrobat, Knowledge of Illustrator CS6 is a plus).

Professional experience

  • (First) experience (2-5 years) in a regulatory affairs environment.
  • Knowledge of and experience with EU and local (BE/NL) regulation of food supplements, (homeopathic) medicines, cosmetics, medical devices, animal feed, …

Language Skills

  • Fluent communication skills in Dutch, French and English (written and oral).

COMPETENCIES / BEHAVIOURS

  • Ability to handle and enjoy complex and changing environments.
  • Positive, optimistic and can-do mindset.
  • Proactive and hands-on mentality.
  • Show ownership.
  • Solution oriented.
  • Excellent communication skills.
  • Open, curious towards potential new developments or out of the box ideas.
  • Strong analytical skills, accurate and detailed while keeping the goal in mind.
  • Ability to handle multiple projects simultaneously.
  • Able to shift gears and to deliver, also within sometimes tight timelines.
  • Eagerness to learn & grow and stay up to date.
  • Identifies with the client’s vision & mission.

Offer

  • A permanent offer
  • An attractive salary package, in accordance to your experience

Information

Kelly Bauwens

kelly.bauwens@medipartner.be

Application

Kelly Bauwens

kelly.bauwens@medipartner.be