Description Overview
Location: Rotterdam or Ghent. Hybrid working model, (3 days onsite, 2 days working remotely per week).
In this role you will manage the Benelux Regulatory Affairs portfolio & projects related to the category ‘skin care, skin healing & parasites’ as required to meet business needs.
You will also ensure compliance with the existing EU and Benelux legislation for cosmetics, biocides and medical devices.
Another key aspect of the role will be supporting in the achievement of the overall cluster Regulatory, Quality & Safety objectives and timely realization of operational activities.
In this position you collaborate closely with the Benelux and Corporate Regulatory, Quality & Commercial colleagues to help the customer the best.
Scope of the Role
Responsible for the Cosmetic, Biocide and Medical Device dossiers in the Benelux skin care, skin healing & parasites category; ensure launch and maintenance is compliant to EU and National regulations and in line with business goals
Provide regulatory input to new product development (NPD), including artwork approvals, label claims and associated supporting documentation
Review and approve, artwork and promotional materials from a regulatory perspective
Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the European territory
Communicate with local regulatory authorities regarding license applications and compliance issues and notice of change
Interpret and implement (inter)national legislation, follow changes in (inter)national regulations and legislations and proactively manage and communicate impact of these changes
Participate to skin category and project meetings as required
Ensure timely and effective communication and collaboration with other departments including commercial, quality and innovation
Liaise with external stakeholders (e.g. Industry associations in Benelux) as the regulatory representative for the companies Skin Care, Skin Healing & Parasites brands
Gather and interpret regulatory intelligence and anticipate on emerging chances in legislation and policy
Analyse regulatory issues incl. impact assessments of changes in regulatory requirements, advise on local implementation strategies and inform relevant stakeholders
Experience Required
Bachelor or Master Degree in a Scientific, Technical or Legal Subject
Minimum 3-4+ years Regulatory Affairs experience within one of the following category cosmetics, biocides, medical devices
Excellent communicator in English and Dutch; French is preferred
Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT and Sharepoint is an asset
Eye for detail, punctual, well organized
Excellent project management and administrative skills
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV
