Biological Product Development Specialist

vor 4 Wochen


Mannheim, Baden-Württemberg, Deutschland Knoell Vollzeit

Knoell: A Leading Service Provider in Biological Product Development

We are seeking a highly skilled Biological Product Development Consultant to join our team. As a key member of our team, you will provide strategic regulatory and technical support to the development and registration of veterinary biologicals.

Key Responsibilities:

  • Provide regulatory advice, technical guidance, and product development strategy in relation to new and existing biological products.
  • Review and critique client documentation intended for regulatory submissions to ensure compliance with relevant regulatory requirements.
  • Apply technical, scientific, and regulatory knowledge to provide clients with scientifically justifiable, regulatory compliant solutions.
  • Prepare high-quality scientific dossiers and documents for regulatory submission.
  • Lead regulatory agency negotiations to obtain new and maintain existing licenses.
  • Participate in multi-disciplinary product development teams and provide expert regulatory knowledge.
  • Develop and maintain an in-depth knowledge of relevant regulatory legislation and guidelines.
  • Establish and maintain effective working relationships with clients to ensure a clear understanding of timelines and scope of work.
  • Manage timely delivery of agreed deliverables on client and internal projects.
  • Actively contribute to internal activities and processes that benefit the team.
  • Represent the company in generating new business leads and pursuing potential business opportunities.

Requirements:

  • Strong technical expertise in all aspects relevant to biological product development, including manufacturing and quality aspects.
  • A working knowledge of the EU Veterinary Medicines regulatory framework, European Pharmacopoeia, and relevant guidelines.
  • Proficient in written and spoken English.
  • BSc in a relevant scientific or veterinary discipline; a higher degree is preferred.
  • A minimum of three years in biological product development gained in the animal health space or related sector.

We look forward to receiving your application.



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