Director Global Regulatory Affairs (biologicals)

The organisation

MSD is working to help the world be well. Through their medicines, vaccines, biologic therapies and animal health products, they work in more than 140 countries to deliver innovative health solutions to patients and animals. MSD also demonstrate their commitment to increasing access to health care through far-reaching programs that donate and deliver their products to the people who need them. MSD has a workforce of almost 4500 in the Netherlands at three main sites. MSD is also known as Merck & Co., Inc. in the US and Canada.

The position

Global Regulatory Affairs (GRA) is accountable for licensing and maintaining pharmaceutical and biological products globally. Global Regulatory Affairs Biologicals is a part of this department and is responsible for the biological product portfolio which consists mainly of vaccines.

The new Director GRA Biologicals will be the head of the Companion animal/Ruminant team (5 persons), and will report to and support the head of GRA Biologicals in the overall management of GRA Biologicals. 

Tasks & responsibilities

• Providing state of the art dossiers, variation and renewal packages for licensing of new biological products and maintenance of the existing biological product portfolio.
• Providing veterinary regulatory expertise for new product development and product maintenance to ensure that relevant regulatory requirements are understood and followed by other relevant MSD AH departments.
• Developing regulatory strategies for new and existing biological products.
• Maintaining the biological portfolio in the market place by providing expert regulatory advise to stakeholders within and outside the company.
• Developing and maintaining contacts with regulatory authorities.
• Participating in regulatory expert groups within the veterinary pharmaceutical industry association(s) to play a role in the development of future veterinary legislation and guidelines.

MSD Animal Health offers motivated candidates an internationally oriented working environment with a high sense of quality where sufficient room for individual initiative is offered. In this fast growing organisation, professionals who are able to convert knowledge concerning content into practical solutions are participating in many new projects. 

Candidate profile

• MSc degree followed by Ph.D.
• Relevant experience in biomedical sciences (virology, bacteriology, molecular biology) or veterinary sciences.
• Five to 10 years’ experience in regulatory affairs within the field of biologicals (vaccines).

Interested?

You are invited to apply to this position by using the form below. For more information you can contact Marije Hoogendoorn, Sr. Recruitment Specialist, Telephone: +31 6 23 13 51 18.