Regulatory Affairs Associate
Duration: 6 months with the possibility of extension and a fixed contract.
Basic purpose of the job:
To actively manage marketing authorisations for the veterinary medicinal products of the company in order to permit the company to legally place and keep its products on the market.
Anticipate and proactively take appropriate regulatory actions to obtain, maintain, extend and renew marketing authorisations. This includes timely preparation and submission of dossiers to regulatory authorities and subsequent follow-up on their progress to approval.
Work closely with the Global regulatory team responsible for products approved through the Central, Decentralized/Mutual Recognition and National procedures, adhering to regulatory submission plans and timelines.
Work closely with Product Manager(s) and Supply Chain, taking into account local business needs in regulatory planning and prioritizations.
Monitor regulatory requirements and relevant legislation as well as a consequence assessment for the current Marketing Authorizations.
Update and maintain the procedures of the department.
Ensure that external and internal databases (e.g. CPD3, BIRDS, WWPPS) are kept up to date.
Tracking, monitoring and executing new and updated labelling and leaflets (PIL) in close collaboration with Corporate labelling and artwork teams.
Translation of regulatory veterinary product literature (PIL) into the Belgian official languages.
Complexity of the regulatory environment combined with the complexity of the different product portfolios of hBI and hMerial with different systems and processes.
Local Marketing, Supply Chain, QA.
International Regulatory Affairs, Corporate Department Operations in hBI and hMerial.
- Experience with regulatory procedures within the EU, pharmaceutical chemistry, pharmacovigilance, pharmacology.
- Knowledge of pharmaceutical terminology and understanding of the development process of a Veterinary Medicinal Product through the system from the final development of the product, through the regulatory procedures at the authorities and final approval and launch of product.
- Degree in Life Science.
- 2 years’ experience in the pharmaceutical industry and demonstrating fundamental knowledge in pharmacology, immunology and pharmaceutical science.
- Independent and meticulous cross-functional team player.
- Thoroughness, commitment, fine attention to details and capable of working with many assignments at the same time without losing overview.
- Proficiency in Excel, Word, Outlook, and database applications.
- Fluent in Dutch and French.
- Very good English skills, written and spoken. Good linguistic and stylistic skills.
Ulrike De Smedt
+32 15 858 034