Regulatory affairs officer
Descripción de la compañía
PB Leiner is one of the world’s leading producers of high quality gelatins and collagen peptides. We supply a growing market in food, pharma, health nutrition and technical applications. In all our efforts, we strive to be the clear solution for our customers. We spot and exploit opportunities, and try to anticipate future trends for them. We pursue outstanding quality and choice, as well as smooth delivery. We have a global presence in terms of both our plants and sales support, and count approximately 1,100 collaborators worldwide. For our HQ in Vilvoorde we are looking for a Regulatory Affairs Officer
Descripción del trabajo
As Regulatory Affairs Officer you act as a link between the company and the regulatory authorities to ensure that products manufactured and distributed are in compliance with appropriate legislation. You specifically focus on trade legislation and support the BU in all import/export related matters, but also deal with other regulatory topics.
- You ensure compliance with, support and advise the BU and all plants on trade legislation and compliance matters (import/export flows, health certificates, HS codes,…) and serve as the trade compliance point of contact for internal customers worldwide
- You work closely together with the colleagues in the regulatory team to ensure compliance with all other relevant regulations (feed, food, pharma, and other applications) and proactively give strategic advice to the BU leadership
- You keep up to date with new and/or changes in the legislations and make sure these are communicated within the company and appropriate measures are taken when necessary
- You monitor this on regional, federal and European level, as well as international with the support of QA and/or supply chain colleagues in the different regions
- You liaise and collaborate with regulatory and trade authorities, where appropriate through Industry Associations, and partners
- You are the RA lead for all supply chain projects
- You ensure that all RA related processes, databases and information systems are optimized, updated and maintained.
- You issue and maintain the compliancy statements of the company as well as documentation and company statements to be distributed amongst customers
- You organize workshops/presentations for internal RA / trade compliance training and education
- You ensure that the cross-regional supply chain, QA and regulatory colleagues function as a team
- You have a Master degree in an appropriate subject (chemistry, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, food or food technology, life or applied science).
- You have a minimum of 3 years’ experience in regulatory affairs, dealing with regulatory authorities and trade legislation and compliance.
- You have Quality Assurance experience
- You have at least knowledge of one of the following domains: food and feed legislation (HACCP, Food safety…); pharma legislation (EDQM…)
- Are a plus:
- Knowledge on trade legislation for products of animal origin
- Knowledge of GxP quality guidelines
- You have a customer-oriented attitude, and are able to communicate with multiple levels in the organization and to explain complicated matters simply
- You are able to work effectively both independently and as part of cross-functional teams
- You have a proactive, entrepreneurial and high self-motivated personality
- You have excellent administrative management skills, you are very detail oriented and analytical
- You are able to work with strict deadlines and have a result driven mindset
- You can manage workload and unpredictable issues, requiring organizational and project management skills
- You are fluent in Dutch and English (strong written and oral communication skills). Knowledge of French, Spanish, Portuguese and/or any other European language is a plus
We offer you a dynamic job in a challenging international environment and an attractive package of conditions
- Nivel de experiencia
- Mid-Senior Level
- PB Leiner