The companyOur client is a professional Pharmaceutical and Biotechnology organisation, based in Oost-Vlaanderen Belgium. Our client is one of the largest and most dynamic companies in the consumer health and personal care industry. The portfolio includes human & veterinary medicines, medical devices, cosmetics, food supplements and biocides. They managed to build a high performance, customer-focused organization which today is directly active in 36 countries, serving a high potential market of prescription-free, consumer-oriented health products. A rapidly expanding company constantly looking for dynamic people who are not afraid of a challenge.
Role description1. To work on global Regulatory Affairs projects supporting business needs in the area of biocides (topical insect repellents mainly) and cosmetics including new product developments, roll-outs and maintenance projects.
2. To help ensuring compliance with the EU Biocidal Products Regulation (EU) 528/2012 and related EU chemicals legislation including REACH and CLP.
3. To help ensuring compliance with the EU Cosmetic Products Regulation (EU) 1223/2009.
Responsibilities1. Work as part of a multi-functional team by providing regulatory input to new product development, launches including artwork approvals, label claims and associated supporting documentation
2. As part of the team support the regulatory process of product maintenance including changes
3. As part of the team ensure product registrations are correct and compliant with the relevant legislation.
A. Create, review, approve and update technical documentation (PIF, PAR, SPC, IUCLID) in compliance with the above mentioned legislations
B. Approve Master Artwork and Master Texts from a regulatory perspective
C. Liaise with local affiliates, responding to regulatory queries and providing and review of registration documents as necessary for the European territory
D. Initiate corrections to Master Documents & Regulatory Affairs Procedures as required
E. Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage impact of these changes
4. Analyze regulatory issues and inform relevant stakeholders of developments in national and EU regulations and legislation and provide regulatory intelligence
5. Carry out other related regulatory affairs duties as required
Requirements• ‘Give it a go’ and positive attitude being keen on creative and problem solving thinking whilst being thorough and focussed with the necessary attention to detail.
• Ability to work on several projects in parallel in a flexible manner both autonomously and in a team environment.
• Good communication skills.
• Passion for regulatory affairs
• Fluent in English
• Master’s degree in Science, Life Sciences, International Law, European Policies or other relevant fields
• At least two years hands-on experience in EU medical device regulatory affairs. Experience with substance based medical devices is a plus
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.