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The Company The company has a Biotech and Pharmaceutical operations site. They are one of the biggest innovative companies in the Netherlands and they are specialized in vaccines, biological therapies and medicines.
Role description
As Senior Specialist you will be working in one of the RA product managers teams of Global Regulatory Affairs Biologicals.
You will be involved in supporting the new licensing activities of several major new product ranges and the regulatory maintenance of existing biological products.
Responsibilities
Prepares and manages timely submission of high-quality state of the art scientific dossiers for efficient licensing of new products and maintenance of existing products
Prepares and manages timely submission of high-quality answers to questions from regulatory authorities during licensing procedures;
Supports the development of regulatory strategies for new and existing biological products;
Participates in visits to authorities to discuss regulatory and technical aspects for new submissions and answering of questions during licensing procedures;
Transfer a Non-GMP environment to a GMP environment
Develops and maintains profound knowledge of all relevant regulatory requirements;
Requirements
Academic education preferably Ph.D in biomedical sciences ( e.g. virology, bacteriology, molecular biology, veterinary sciences)
Excellent oral and written command of the English language; Excellent writing skills.
Effective communicator and negotiator;
Basic knowledge of project management
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