Senior Consultant (CMC Small Molecules

Senior Consultant (CMC Small Molecules) UK

Bishop's Stortford, United Kingdom | Posted on 31/07/2026

• Industry Pharma/Biotech/Clinical Research
• Province Hertfordshire
• City Bishop's Stortford
• Postal Code CM23 2EJ
• Country United Kingdom

Scendea is an international product development, regulatory, and compliance consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide.

Scendea’s expert team delivers strategic and operational support in the fields of Non-Clinical, CMC, Clinical, Regulatory and Compliance to successfully guide products from early development to marketing approval.

Scendea is seeking a highly motivated individual to join ourglobal team as a full-time Senior Consultant (CMC small molecules). Thisis a hybrid position, affiliated to our UK Bishop's Stortford office, with arequirement to work in the office a minimum of one day per month.

This is an excellent opportunity to progress your career at a rapidly growing product development, regulatory, and compliance consulting group. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development.

• Provide strategic, technical and regulatory advice/services to clients with aspecial interest in Chemistry, Manufacturing, and Controls (CMC) development of human medicinal products.
• Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
• Provide innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products withinthe changing regulatory environment.
• Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Paediatric plans/applications, Investigator Brochures, IMPDs,Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, DMFs according to area of expertise.
• Leadmulti-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
• Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
• Ensuredelivery of project goals within agreed timelines, maintaining oversight of project budgets.
• Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
• Support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients.
• Linemanage, train, and mentor members of the Scendea Operational team, includingproviding technical leadership.

• Ahigh scientific calibre with a relevant science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent(e.g., a life/physical science focused MSc or preferably a PhD).
• Aminimum of 5 years drug development experience.
• Aminimum of 5 years regulatory experience, working with either the FDA,MHRA, and/or EMA submissions, including meetings/negotiation. Regulatory experience may include time within a National Competent Authority.
• Authoring of CMC sections of regulatory documentation is required. MAA/BLA Experience is highly desirable.
• Demonstrated experience with a broad range of products, including recombinant proteins and peptides (including antibodies), prophylactic and therapeutic vaccines,biosimilar products, advanced therapy medicinal products (tissue, cell andgene therapy), RNA or DNA based products, live biotherapeutics and small molecule NCE and/or generic chemical entities.
• Direct experience preferred in providing strategic regulatory planning from early-stage development up to marketing authorisation, and a proven ability to defineand deliver creative scientifically driven solutions to technical development and regulatory issues.
• Proven ability and willingness to lead a team and deliver education and…