Product Manager Regulatory Affairs

  • Boxmeer
  • 5000.00 - 6000.00
  • 40 hours
  • Master degree

Client

Our client is a leading project management and engineering company for industry around the world.

Client

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence.

They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

Requirements

  • Academic education followed preferably by Ph.D. (or equivalent experience) in biomedical sciences (e.g. virology, bacteriology, molecular biology, veterinary sciences);
  • 8 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.
  • Excellent command of the English language;
  • Effective communicator and negotiator;
  • Flexible and persistent personality. Service and compliance minded.
  • Ability to work in a matrix and multi-cultural environment;
  • Attention for details.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

  • Supporting the licensing activities required for the maintenance of existing biological products, such as improvements of manufacturing process and/or quality control tests.
  • Submission of scientific dossiers for licensing of new products and maintenance of existing products (i.e., variations, renewals);
  • Prepares and manages answers to questions from regulatory authorities during licensing procedures;
  • Visits to authorities to discuss regulatory and technical aspects for new submissions
  • Develops and maintains profound knowledge of all relevant regulatory requirements;
  • Supports the development of regulatory strategies for new and existing biological products;
  • Actively following the development/emergence of new regulatory requirements, to support the assessment of their potential impact for new product development and product maintenance and to develop regulatory strategies to cope with future requirements;
  • Participates in multidisciplinary product development and maintenance teams to provide veterinary regulatory expertise.

TAGCLOUD

virology
#bacteriology
#molecularbiology
#veterinarysciences
#regulatory
#affairs
#regulatoryaffairs
#GMP
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (1108)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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