Regulatory Affairs

Location: Boxmeer, Noord-Brabant  |  Sector: Pharmaceuticals  |  Start Date: 6/26/2024  |  Job ref: 52977

Regulatory Affairs Specialist

The Company
Our client is a multinational healthcare company whose aim is to provide innovative medicines vaccines and animal health products globally.

Role Description
As a Regulatory Affairs Specialist you will be part of a project team involved in updating the product information for all biological products licensed within the European Union as required by the New Veterinary Regulation. The focus of your activities will be the content of the required regulatory submissions. In addition, you will provide support for the licensing activities of new products 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.
– Develops and maintains profound knowledge of all relevant regulatory requirements.
– Supports the development of regulatory strategies for new and existing biological products.

 Requirements
– Holding a PhD/ master’s degree in related field or BSc with relevant experience.

Knowledge of or several years of experience in the pharmaceutical industry.
– Excellent oral and written command of the English language; Excellent writing skills.
– Flexible and persistent personality. Service and compliance minded.

 Other information
Are you interested? Feel free to contact me!

 

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