Regulatory Affairs Officer

Location: Boxmeer, Noord-Brabant  |  Sector: Biotechnology  |  Start Date: 11/6/2023  |  Job ref: 51778

The Company
Our client is a multinational pharmaceutical company that is renowned for its expertise in discovering, developing, and manufacturing cutting-edge medicines, vaccines, and animal health products. With a global presence, they actively engage with healthcare professionals, governments, and organizations to tackle unmet medical needs and enhance patient well-being.

Role Description
As a Regulatory Affairs Officer you will be responsible for updating product information for all biological products licensed in the European Union, following the New Veterinary Regulation. Your main job will be handling the licensing parts of the necessary regulatory submissions. You will assist in licensing new products and maintaining the regulations for existing biological products.

– Manage all basic licensing procedures and, with assistance, handle complicated licensing procedures.
-Provide guidance on routine licensing procedures to less experienced team members.
– Communicate directly with officials to talk about the licensing parts of regulatory applications.
– Build and keep in touch with regulatory authorities.
-Prepare and submit thorough and timely responses to inquiries from regulatory authorities during intricate licensing processes.
-Contribute to overall regulatory affairs projects involving document management systems or regulatory databases.

– A university degree or a similar HBO bachelor’s degree in veterinary science, (Bio) Chemistry, Biology, or Biomedical Science is desirable.
– A minimum of three to five years of experience in (veterinary) regulatory affairs, especially in the field of biology.
– Familiarity with or experience in developing and maintaining products for the (veterinary) pharmaceutical sector is preferred.
-Capable of recognizing complex (licensing) issues, analyzing them, and offering potential solutions.

Other information
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

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