Principal CMC - Biologicals - Consultant
Proclinical is in partnership with a leading Regulatory Consultancy in search of a Principal CMC - Biologicals Consultant. You will work with an international team offering strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory.
- Provide strategic, technical and regulatory advice/services to clients in the area of Chemistry, Manufacture and Controls for the development of human medicinal products.
- Focus should be on biotechnological products and experience shall ideally include recombinant proteins (including antibodies), prophylactic and therapeutic vaccines, biosimilar products, and advanced therapy medicinal products
- 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 Chemistry Manufacture and Controls perspective for complex products within the changing regulatory environment.
- Educate clients on current regulatory trends and expectations. Where relevant, champion the client's view for development of products with other contractors such as CMOs and Qualified Persons.
- 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.
- Preference for candidates who have direct experience to providing strategic regulatory planning for the delivery of industry development goals up to marketing authoritisation.
- High level of computer literacy and competency in MS Office programs.
- A competitive salary, which is commensurate with experience.
- Generous bonus program, which rewards success.
- An opportunity to influence global business strategy, and associated implementation.
- A challenging and stimulating position for a dynamic and competent regulatory professional, who wishes to contribute to a growing business and a rapidly expanding team.
- Coaching and mentoring to support your continuous development.
- A unique working environment driven by strong company values and a very high level of employee engagement across the international organisation.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.