Biological Product Development Specialist
vor 2 Wochen
Unlock Your Potential in Biological Product Development
Knoell is a leading global service provider in regulatory registration, clinical development, and product development support for clients. Our team of scientific and regulatory experts, along with our extensive network of partners, ensures that all regulatory requirements are met from the project outset to support our clients' global business.
Our Strength is Global Thinking, Local Action
Role DescriptionThe successful candidate will provide strategic regulatory and technical support to the development and registration of veterinary biologicals.
Your Key Responsibilities- Provide regulatory advice, technical guidance, and product development strategy for new and existing biological products.
- Review and critique client documentation intended for regulatory submissions to ensure compliance with 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.
- 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.
- Ideal candidate has a minimum of three years in biological product development gained in the animal health space or related sector. Appropriate research experience will also be considered.
- The successful candidate must demonstrate aptitude to develop and grow with the business; must be an empathetic team player; professional and enjoy working flexibly within a highly motivated team.
We look forward to receiving your application.
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