Regulatory Affairs Specialist
Offer
- a challenging job within a large pharmaceutical company
- a temporary assignment for year
- contract of Derks & Derks Secondment & Interim
Position
As a Regulatory Affairs Specialist you and your Global Regulatory Affairs (GRA) team are accountable for licensing and maintaining pharmaceutical and biological animal health products globally. GRA Biologicals is a part of this department and responsible for the biological product portfolio. You will provide state of the art dossiers, variation and renewal packages for licensing new biological products and maintenance of the existing biological product portfolio. You will also provide veterinary regulatory expertise for new product development and product maintenance to ensure that relevant regulatory requirements are understood and followed by other relevant departments. You develop regulatory strategies for new and existing biological products. You will maintain the biological portfolio in the marketplace by providing expert regulatory advice to stakeholders within and outside the company. You will develop and maintain contacts with regulatory authorities and participate in regulatory expert groups within the veterinary pharmaceutical industry association(s) to play a role in the development of future veterinary legislation and guidelines.
Profile
- MSc. Degree, followed preferably by Ph.D. (or equivalent experience) in biomedical sciences (e.g. virology, bacteriology, molecular biology, veterinary sciences);
- knowledge of or several years of experience in the (veterinary) pharmaceutical industry in the development and/or maintenance of products, and in regulatory affairs, preferably in the field of biologicals is an asset;
- 60% on site/40% from home;
- excellent oral and written command of the English language;
- excellent writing skills.
Organisation
Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Boxmeer. The location has approximately 45 employees who are responsible for marketing, sales, distribution, and support of the products.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to MSP/24-242-DD to Marlies Dingemans: info@derksenderks.nl. For more information, please call Marlies via 0334728087.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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