Junior Regulatory Affairs Scientist/Writer - Belgium
- Our company is a consultancy firm in EU regulatory affairs,(5 min. walking distance from the central station).
- We provide strategic and hands-on regulatory support in various therapeutic areas ranging from life-threatening diseases to OTC and borderline products.
- By concentrating exclusively on regulatory affairs, we can offer in-depth knowledge, insight, skills, and experience.
- We have a unique team of junior and senior consultants in place with a heart and talent for regulatory affairs.
- Our company is looking for a Regulatory Affairs Scientist and/or Regulatory Affairs Scientific Writer to join our team.
- Supported by our team, you will support our clients in scientific aspects of regulatory affairs of medicinal products. This can include:
- A role as Scientific Writer of several parts (quality i.e. CMC information, non-clinical information, clinical information) of dossiers (such as clinical trial applications, scientific advice briefing books, orphan drug designations, pediatric investigation plans, MAAs/Variations) that will be submitted to the regulatory authorities.
- Contribution to defining a sound regulatory scientific strategy for development and life cycle management of medicinal products.
- Bachelor, Master or PhD in a scientific discipline relevant to the development and life cycle management of medicinal products e.g. pharmacy, biology, chemistry, biomedical sciences, bio-engineer.
- Scientific background and keen interest in scientific aspects of medicinal products. Scientific background in specialized areas of medicinal product development such as biologicals, infectious diseases, oncology, immunology or other is a plus.
- Exposure to or initial experience with regulatory affairs and elements of drug regulation is an asset.
- Excellent language skills in English, Dutch. French is a plus.
- Clear and effective written and oral communication skills.
- Very good writing skills in English and passionate about analyzing scientific information and presenting scientific data in an accurate and clear way.
- Capable to efficiently work with MS Word, Excel, Power Point.
- Proactive attitude and fast learner.
- Customer minded and quality output driven.
- A dynamic person and team player who can operate in a flexible working environment.
- Positive and pleasant personality with effective interpersonal skills.
- Ability to cope with changing priorities and multi-tasking.
- A competitive remuneration package.
- Varied job in a young and dynamic environment.
- Coaching by seasoned regulatory affairs colleagues, passionate by regulatory affairs.
- Opportunity for continuous learning and to follow external training courses