Director Global Regulatory Affairs Biologicals Job - Netherlands
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- Our company is working to help the world be well.
- Through our medicines, vaccines, biologic therapies and animal health products, we work in more than 140 countries to deliver innovative health solutions to patients and animals.
- We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them.
- Our company has a workforce of almost 4500 in the Netherlands at three main sites.
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.
Major activities of GRA Biological are:
- 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 company 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.
- To direct and be accountable for the regulatory activities for part of the Biological portfolio (Companion animals/Ruminants).
- To actively support new development projects or products.
- To facilitate and ensure the timely provision of state of the art dossiers, advice and technical input for efficient new licensing and life cycle management.
- To facilitate and support the work of other RA product managers.
- To maintain and develop a profound knowledge of regulatory requirements for major animal health markets such as the European Union, EU-like countries (e.g. Australia) and the BRIC countries (Brazil, Russia, India and China) in order to design optimal global regulatory licensing strategies aimed at coping with future licensing requirements.
- To ensure regulatory compliance.
- To represent Global Regulatory Affairs at international organisations and meetings in order to play a pivotal role in the development of future veterinary legislation and guidelines.
Academic followed by Ph.D. with relevant experience in biomedical sciences (virology, bacteriology, molecular biology) or veterinary sciences.
- Five to 10 years’ experience in regulatory affairs preferably within the field of veterinary vaccines;
- Experience in (veterinary) vaccine research, vaccine production or quality control is an advantage;
- Profound knowledge of English speaking and excellent writing skills;
- Strong and effective communicator and negotiator; flexible and persistent personality;
- Good team-player skills;
- Good networker – proven ability to efficiently interact within complex organizations;
- Proven ability to maintain an overview of multiple projects/products;
- Proven ability to work under high pressure and to meet critical timelines;
- People manager skills.
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