Regulatory CMC Biologics Consultant
A leading biotechnology company is seeking to recruit an Regulatory CMC Biologics Consultant to their office in London. The company is known for their work in developing therapeutics that treat rare genetic diseases, some of which affect as few as 1000 people worldwide. This is an exciting opportunity to join a dynamic global business and support its commercial presence across Europe, along with other regions.
- Providing EU Strategic input on CMC expectations for product development in early and late phase clinical trials.
- Providing EU Strategic input on CMC expectations for post approval variations.
- Collaborating with internal and external partners to provide high quality submission in line with Company objectives and timelines.
- Assessing of manufacturing changes within the Phase 1-3 and post approval environments.
- Planning and execution of submissions and responses to questions.
- Interacting and with subject matter experts, as required.
- Managing and communicating review outcomes to impacted stakeholders.
- Representing the EU Reg CMC team on process enhancement initiatives.
Skills and Requirements:
- BSc or higher degree in life sciences in biology, chemistry, molecular biology, or similar is required Ph.D.is preferred.
- Strong knowledge of the manufacturing of biological medicinal products with proven relevant EU CMC Regulatory Affairs experience.
- Extensive knowledge and experience of EU CMC Reg Affairs guidelines and regulation relevant to biological medicinal products
- Change control assessment.
- IMPD authoring.
- Variation/lifecycle submission authoring, reviewing and management.
- Interaction with EMA or other Regulatory Authorities.
- Collaborative, knowledgeable, organized, good and consistent communicator with attention to detail.
- Proven time management skills and the ability to prioritise tasks.
- Demonstrate initiative and the ability to work independently.
- Proven ability to work as part of a cross functional/cultural team.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at 0203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.