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Regulatory Affairs Associate
Are you looking for a new challenge in your career? You enjoy working in Regulatory Affairs while being part of a committed, passionate, and fun team? Then this challenge is for you!
As one of our new Regulatory Affairs (RA) Associate in Animal Health, you will gain great knowledge and understanding of every aspect behind the marketing and sales of Veterinary Medicinal Products from final product development, clinical trials, marketing authorization, to Pharmacovigilance of products for the Belgian market.
You will play a key role by providing all regulatory support for Belgium and Luxembourg for our veterinary products (medicinal, biocide and complementary feed). According to the local regulatory requirements and ensuring compliance of the overall process, you will monitor the progress of all procedures whilst adhering to the best practice principles and the global regulatory strategy of Animal Health medicines.
YOUR KEY RESPONSIBILITIES
- Establish and maintain contact with internal and external stakeholders
- Update and translate Summary of Product Characteristics (SmPC), labelling and Insert Leaflets (Product Information Literature - PIL) as well as prepare and approve of texts and layout for labels and leaflets (artwork)
- Update and maintain the (Standard Operating) procedures of the department, budget files and internal and external databases and systems
- Give internal pharmaceutical and regulatory service to Marketing, Supply Chain and Quality Assurance
- Assist in the preparation, maintenance, and submission of regulatory documentation (e.g., variations and renewals) to the competent authorities in Belgium and Luxembourg
- Plan and execute activities, based on assigned tasks within the agreed timelines and in accordance with the company’s guidelines and procedures.
- At least Bachelor’s Degree in Life Sciences, Pharmaceutical Sciences, Veterinary or another field
- Preferably 1-2 years of working experience in the pharmaceutical industry or authority
- Knowledge and understanding of the regulatory processes is an advantage
- Knowledge of local and international regulatory affairs regulations is an advantage
- Knowledge of the various RA documentation systems and software is an advantage
- Excellent command of Dutch and English languages. Good knowledge of French
- Knowledge of the German language is an asset
- Independent and detail oriented
- Cross functional team player and open to digital agile ways of working
- Strong organizational and communication skills
- Proficiency in Excel, W ord, Outlook and database applications
- A challenging position within a globally operating, fast-growing, venturous company with a strong market position
- A good balance between work and free time (Mix of working from home / office as well as flexible working hours)
- Working in a passionate team within a fun, diverse, and multicultural working environment
Position specific training opportunities for your personal and professional growth (+ Access to learning platforms)
- Full time basis with 20 legal holidays and 12-time reduction days
- Competitive salary package and extralegal benefits.