Jobid: 3195966357 (0.11)
Overview
In this role you support regulatory activities to secure submissions, approvals and launches for new and existing products. You will advise cross-functional teams and external stakeholders on market access, labeling, and packaging in a fast-changing regulatory landscape. You’ll contribute to product registrations, lifecycle maintenance, and promotional material review, ensuring compliance and timely delivery. This is a global, collaborative position with the chance to shape regulatory strategy and drive successful market access. You will work closely with multiple departments to translate complex regulations into actionable plans.
Arbeidsvoorwaarden / Benefits
- hybrid workspace
- competitive compensation
- comprehensive benefits
- training and coaching
- career development opportunities
- autonomy and continuous improvement
Verantwoordelijkheden
- Execute regulatory activities per project plans to meet submission, approval and launch goals
- Involve in product lifecycle including NPD, launches, lifecycle maintenance and promotions
- Support change management for existing products with manufacturing and procurement
- Maintain labeling in compliance with local and EU laws; develop and approve label specs
- Support development and approval of packaging materials on time
- Process change requests per GMPs and regulations
- Maintain regulatory files and data systems per SOPs
- Coordinate with marketing, trade marketing, sales and corporate regulatory and innovation
- Review technical documentation and manage regulatory submissions timely
- Process feedback from regulatory authorities and notified bodies
- Support development and clearance of promotional materials
- Provide input for data analysis or management reviews if required
- Assist in reporting and investigating critical non-conformities and improvement opportunities
Belangrijkste vereisten
- Master’s degree in Life Sciences, Foods, Pharmacy, or related field
- At least 4 years of Regulatory Affairs experience
- In-depth knowledge of local and EU regulations (Benelux + medicines, medical devices, food supplements, biocides, cosmetics or general health products)
- Strong communication and project management skills
- Ability to work autonomously in local and international teams
- Strong communication, persuasion and problem-solving skills
- Curiosity and quick learning mindset
- Fluent in Dutch and English (French and German a plus)
- Strong communication
- Project management
- Problem-solving
- Regulatory submissions
- GMP compliance
- Labeling and packaging compliance
Deel deze vacature: