As team member of the European Regulatory Affairs group you will support and advice the business on regulatory issues at sourcing, introduction, maintenance, marketing and sales of new and existing suppliers, products and product ranges.
KEY TASKS – MAJOR JOB DUTIES & RESPONSIBILITIES
- Establish and maintain appropriate knowledge to ensure Regulatory Compliance with applicable state, federal and international laws
- Review new and existing EMEA regulatory guidance documents, and assess impact on VWR business
- Review labeling/marketing material for compliance with applicable regulations and standards
- Research the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies
- Working within the Life Sciences product managers, Regulatory Affairs team, providing regulatory and scientific advice to other areas of the Organisation
- Build up, maintain and follow up contacts with the necessary competent Authorities
- Supplier and product on boarding and contract approval
- Maintain and review REGA master files
- Support master data team and liaise with the supplier to ensure regulatory requirements are maintained properly.
- Provide regulatory support to the sales, marketing, sourcing team and management
- Interact with the local Regulatory Affairs, with European and local Quality Managers, Category Management, Procurement, Scientific Advisory Board, Central Planning, Logistics, Sales, suppliers and manufacturers