This job is currently Archived,
Senior Associate Regulatory Affairs - Pharmaceuticals - Belgium
Posted on : 04 April 2017
R&D - Veterinary Medicine Regulatory Affairs
- Our company continuously innovates to develop animal health solutions to meet the needs of those who raise and care for animals.
- The R&D organization develops products to prevent and treat diseases, by relying on world-class talent, teamwork and pioneering science.
- The Veterinary Medicine Regulatory Affairs department provides regulatory expertise, support and guidance to the R&D organization on the required data and documentation that is needed to meet all current regulatory and legislative requirements.
- In addition, they advise what regulatory strategy to implement in order to optimize the value of company assets, to ensure the approval of new medicines and the maintenance of existing medicines (Vaccines, Pharmaceutical and BioPharmaceutical) products.
- Would you like to work at the EU headquarters of one of the leading companies within animal health offering opportunities for personal growth?
- Would you like to combine your scientific background with creativity?
- Do you like variation in your job?
- Are you dynamic, a team player and would you like to work with different nationalities?
- If yes, this might be your opportunity!
- You will be responsible for the implementation of regulatory strategies, you will obtain and maintain marketing authorizations for products and communicate general regulatory requirements in support of licensing of products in Europe, Middle East and Africa.
With the guidance of an experienced Regulatory Manager and depending on your own experience:
- you will be accountable for the registration, variations and renewals of your product portfolio within Europe, Africa and Middle East:
- prepare and submit through EU Regulatory procedures, in a timely manner, regulatory dossiers according to regulatory requirements
- do the necessary follow-up on your portfolio to speed up approvals
- liaise with different regulatory authorities to discuss scientific topics
- liaise with colleagues from R&D, chemistry, marketing, logistics and other European Regulatory colleagues to solve questions
- provide necessary input for the correct labelin
- you will contribute to the development of new medicines.
- You will participate on project teams and will give advice on the regulatory requirements and on the most appropriate regulatory strategy.
Experience and background
- You are a graduate in Pharmacy, Veterinary sciences, Life sciences, Bio-Sciences or Chemistry. A PhD is an asset.
- Experience within Regulatory Affairs at national or European level is an advantage, but is not essential.
Technical Skills Requirements
- team player
- good communication and interpersonal skills ensuring the ability to interact with the business and authorities in a professional manner
- punctual and accurate
- whilst remaining focused on strategic goals, you have the ability to multi-task and to work to demanding and aggressive timelines
- negotiation skills
- technical skills (Word, Excel, databases, online research,…)
- ability to multi-task and to work to demanding timelines, whilst remaining focused on strategic goals
- Our company is a global animal health company dedicated to supporting customers and their businesses in ever better ways.
- Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services.
- We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.