Part Time à Malaisie

Biologicals Product Development Consultant (f/m/d)

Full or Part Time Europe Experienced Professional August 01, 2023 Hybrid Remote

Company Overview

knoell is one of the leading global service providers in offering regulatory registration, clinical development and product development support to clients. Our team of scientific and regulatory experts and extensive network of partners ensures that all the different regulatory requirements are right from the project outset to support our client’s global business. People are at the heart of our family-owned business and our values guide the way to our success. Team spirit and mutual support are very important to us. Our culture is characterised by strong international co-operation, can-do attitude, focus on quality and a growth mindset.

Our strength is to be where it matters - think globally, act locally!

ROLE DESCRIPTION

The position holder will provide strategic regulatory and technical support to the development and registration of veterinary biologicals.

YOUR TASKS

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

KEY REQUIREMENTS

1. Strong technical expertise in all aspects relevant to biological product development (vaccines and/or biotherapeutics) including manufacturing and quality aspects.
2. A working knowledge of the EU Veterinary Medicines regulatory framework, European Pharmacopoeia and relevant guidelines.

YOUR PROFILE

1. Proficient in written and spoken English.
2. BSc in a relevant scientific or veterinary discipline; a higher degree is preferred.
3. Ideally 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.
4. 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!