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RA Technical Regulatory Writer
Experis Life Sciences is your partner in your research for professional opportunities.
Our expertise and our large client portfolio in the pharmaceutical, chemical and food industries allows us to make the good connections between your experience, your expectations and the needs of the market.
You will have the opportunity to enter various departments (R&D, Production, Supply Chain,
QA, QC, RA, ...) according to your interests.
Interested by regulatory affairs and medical affairs ? You want to work in an innovative and international pharmaceutical industry?
This position is for you.
Your responsibilities :
- You directly communicate with RA team members to develop global regulatory project plans, including a detailed list of submission deliverables, dependencies, approval timing and cost.
- You support the life-cycle of the product by facilitating and delivering regulatory strategy (technical/CMC and procedural aspects)
- You compile and write regulatory documentation in accordance with regulatory requirements.
- You create and maintain overall schedule for global registration activities, and communicate accomplishments and risks to global project team
- You coordinate responses to regulatory authority queries with strict deadlines
- You interact with internal and external stakeholders (labelling, safety, epidemiology, clinical, technical Experts,…)
- You maintain and update existing regulatory authorizations
Do you recognize yourself in this mission and want to know more?
Contact me :
If you do not find yourself in this offer but are looking for opportunities in the pharmaceutical industry, feel free to send your CV and visit our website www.experis.be
Other opportunities are available and may be suitable for you.
- You have a university degree in science or equivalent experience in the pharmaceutical industry
- You have a knowledge of international regulatory standards (CFR, Eurdralex,…)
- You have excellent written and verbal communication skills
- Technical system skills (e.g. word processing, spreadsheets, Microsoft Project, databases, online research, SharePoint)
- You have negotiation skills and you are able to identify risks and escalate when necessary
- You are bilingual (French/English)
Our offer :
- You will sign a permanent contract
- You will receive several extra-legal benefits (company car, group and hospital insurance, lunch allowance,...)
- You will benefit from a personalized follow-up (training, follow-up of your career plan,...)
- You will work in a dynamic and challenging environment
Matthieu De Clercq
32 2 639 10 70
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2 days left to apply
- Function type: Consultancy
- Sector: Chemistry and Pharmacie
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