Daily new jobs


Global Regulatory Affairs Associate/Senior Associate (biocides & cosmetics)

Share on social media:

Apply Save this job

2 people also applied on this job

The company

Our 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 description

1. 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.


1. 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


• ‘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

Other information

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.

Job alert

  • No registration required
  • Stay up-to-date on the latest jobs

SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 21-03-2019
Country: Belgium
Region: Oost-Vlaanderen
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: English
Sector: Pharmaceutical
Specialisation: Regulatory Affairs

Search again

Related jobs

Ewout de Jong
Compliance Specialist Medical Devices

Regulatory Affairs

SIRE Life Sciences®
Quality Engineer Temp (6-12 months)

Regulatory Affairs

Ewout de Jong
Auditor Manager Medical Devices

Regulatory Affairs

Ewout de Jong
Auditor Medical Devices

Regulatory Affairs

Ewout de Jong
Snr Quality Associate Medical Devices

Regulatory Affairs


SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Staffing Solutions B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE Life Sciences Consultancy B.V.

Wetenschapsstraat 14B
1040 Bruxelles
+32 (0) 2 588 1277