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.

Job Responsibilities

• 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.

Benefits

• 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.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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