Principal CMC - Consultant
A leading Regulatory Consultancy is in search of a Principal CMC - Consultant to provide strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory, which guide products efficiently from early development to marketing approval.
- Provide strategic, technical and regulatory advice/services to clients in the area of nonclinical and clinical development of human medicinal products.
- Focus should be on medicinal products and experience shall ideally include recombinant proteins (including antibodies), prophylactic and therapeutic vaccines, biosimilar products, and advanced therapy medicinal products (tissue, cell and gene therapy). Interest in the development of NCE and/or generic chemical entities is an advantage.
- Provide innovative drug development plans, data gap analyses and international regulatory strategies from a Nonclinical/Clinical perspective for complex products within the changing regulatory environment.
- Contribute to technical authorship of Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, Clinical Trial Applications, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications
- Educate clients on current regulatory trends and expectations. Where relevant champion the client's view for development of products with other contractors such as CROs.
- Represent clients in regulatory agency interactions and providing regulatory solutions to agency objections.
- Challenge the regulatory 'status quo' from a technical and scientific standpoint.
- Provide technical leadership to other members of the consultancy team, including other Principal and Senior Consultants.
- Mentoring and training junior members of the consultancy team (including Senior, Consultant and Associate levels)
- Supporting Business Development in sales/marketing introductions, preparation of project proposals & educational materials
- Provide strategic input/support to Directors and the company's growth plan.
- Maintain oversight of project budgets.
- Ensure delivery of project goals within agreed client/team timelines.
Skills and Requirements
- Life Science Postgraduate degree level, preferably PhD - although MSc with significant employment experience considered.
- A professional manner and presentable appearance for meeting customers/clients.
- Ability to work in a proactive and autonomous manner as well as leading a global team.
- At least fifteen years of drug development experience, with at least five years in the area of biotechnology a regulatory affairs.
- Ability to balance competing priorities and complete work within a set time-frame.
- Exemplary organisational skills with a high level of attention to detail.
- Exemplary verbal communication and presentation skills.
- High level of computer literacy and competency in MS Office programs.
- RAC/TOPRA accreditation is an advantage.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.