Senior Regulatory Affairs Specialist

Location: Haarlem, Noord-Holland  |  Sector: Biotechnology  |  Start Date: 6/28/2024  |  Job ref: 53002

About the Company
Our client is a trusted global leader in veterinary medicine, dedicated to improving the health and well-being of animals. Their innovative products, services, and technologies aim to prevent, treat, and control diseases in farm and companion animals. They are committed to making a positive impact on animal care and the world’s food supply, with a deep sense of responsibility toward customers, consumers, animals, society, and the planet.

About the Position
We are seeking a Senior Specialist – RA Product Manager to join our client’s Global Regulatory Affairs (GRA) team at their Boxmeer facility. This role is crucial for licensing and maintaining pharmaceutical and biological animal health products globally. You will be part of a project team focused on updating product information for all biological products licensed within the European Union, ensuring compliance with new veterinary regulations. Additionally, you will support the licensing activities of new products and the regulatory maintenance of existing ones.

Responsibilities

  • Prepare and manage timely submissions of high-quality scientific dossiers for licensing new products and maintaining existing ones.
  • Provide high-quality answers to regulatory authorities during licensing procedures.
  • Participate in meetings with regulatory authorities to discuss submissions and answer questions.
  • Develop and maintain knowledge of relevant regulatory requirements.
  • Support the development of regulatory strategies for new and existing biological products.
  • Monitor new regulatory requirements and assess their impact on product development and maintenance.
  • Provide veterinary regulatory expertise in multidisciplinary teams to ensure compliance with relevant regulations.

Requirements

  • Academic education in biomedical sciences (e.g., virology, bacteriology, molecular biology, veterinary sciences); Ph.D. preferred or equivalent experience.
  • Experience in the veterinary pharmaceutical industry, particularly in product development and regulatory affairs, with a focus on biologicals.
  • Excellent oral and written English skills; strong writing capabilities.
  • Effective communicator and negotiator with a flexible and persistent personality.
  • Team player with the ability to work under pressure and meet deadlines.
  • Ability to work in a matrix and multi-cultural environment.
  • Attention to detail and basic project management knowledge.

Join our client’s dynamic and international environment where your work can make a real impact and where there is plenty of room for personal development. Apply today!

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