Barrington James
Senior Regulatory CMC Consultant – Biologics & ATMP
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Senior Regulatory CMC Consultant – Biologics & ATMP
Location: Remote – England or Belgium
Employment Type: Full-time, Permanent
Working Model: Fully remote with occasional travel for client meetings, industry conferences, and business development activity
About the Role
We are seeking an experienced Senior Regulatory CMC Consultant to join a growing specialist consultancy supporting pharmaceutical and biotechnology clients across the development and regulatory lifecycle of complex biological products.
This is a senior, client-facing position combining hands-on Regulatory CMC dossier authoring with client engagement, industry networking, and business development.
The successful individual will bring strong experience in biologics regulatory CMC, with a proven track record of contributing to and authoring Module 3 content for regulatory submissions. Experience supporting BLA submissions is highly desirable, alongside exposure to global regulatory strategies and an understanding of the complexities associated with biologics manufacturing and control.
The role will also provide the opportunity to help shape the consultancy's growth by developing relationships within the biotechnology and pharmaceutical sector, attending industry conferences, and contributing to the company's external market presence.
Key Responsibilities
Regulatory CMC & Technical Consulting
- Lead and contribute to the authoring, review, and compilation of Module 3 CMC documentation for biologic drug products.
- Prepare high-quality regulatory content covering areas such as drug substance, drug product, manufacturing processes, process controls, analytical methods, specifications, stability, and comparability.
- Support regulatory submissions across different stages of development, including IND/IMPD, BLA, MAA, and post-approval activities, depending on client requirements.
- Review technical and CMC documentation generated by clients, CMOs/CDMOs, and internal project teams.
- Work closely with clients to translate complex scientific and manufacturing information into clear, accurate, and regulator-ready documentation.
- Support CMC regulatory strategy, identifying potential gaps, risks, and opportunities within development programmes.
- Contribute to responses to regulatory authority questions and requests for additional information.
- Work across a range of biologic modalities, potentially including monoclonal antibodies, recombinant proteins, vaccines, and other complex biological products.
- Provide support on Advanced Therapy Medicinal Products (ATMPs) where appropriate.
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Client Engagement & Consulting
- Act as a trusted CMC regulatory advisor to pharmaceutical and biotechnology clients.
- Participate in client meetings, workshops, and project calls to understand regulatory and technical requirements.
- Develop strong relationships with scientific, CMC, regulatory, and executive stakeholders.
- Provide pragmatic regulatory advice based on both technical expertise and an understanding of client priorities.
- Support the delivery of high-quality consultancy projects from initial scoping through to completion.
Business Development & Market Development
- Alongside technical delivery, the role will have an important role in supporting the continued growth of the consultancy.
- Build and strengthen relationships across the biopharma, biotech, CDMO, and life sciences ecosystem.
- Attend relevant industry conferences, congresses, and networking events to identify new opportunities and strengthen the consultancy's market presence.
- Participate in client meetings and business development discussions alongside senior leadership.
- Identify emerging market needs and areas where the consultancy can support clients.
- Contribute to the development of proposals, statements of work, and client presentations.
- Develop and maintain a professional presence on LinkedIn, sharing relevant regulatory, CMC, and industry insights to increase market visibility.
- Help build a network of prospective clients and industry contacts across Europe.
- Support the consultancy's longer-term commercial pipeline while maintaining a strong technical focus.
Background & Experience
We are looking for an experienced Regulatory CMC professional with a strong technical foundation and the confidence to operate in a client-facing consulting environment.
Essential
- Significant experience working in Regulatory CMC within the pharmaceutical, biotechnology, or consultancy environment.
- Strong experience with Module 3 authoring and review.
- Proven experience supporting biological products.
- Experience with BLA submissions or equivalent major global biologics submissions.
- Strong understanding of biologics CMC development, manufacturing, and control strategies.
- Ability to interpret complex technical information and convert it into clear regulatory documentation.
- Strong written and verbal communication skills.
- Comfortable working directly with clients and senior stakeholders.
- Ability to work independently within a fully remote consultancy environment.
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Desirable
- Experience across multiple biologic modalities.
- Experience supporting ATMPs / cell and gene therapy programmes.
- Experience with FDA and EMA regulatory submissions.
- Experience supporting regulatory authority interactions and responses.
- Previous experience within a specialist consultancy or client services environment.
- Existing network across the biotech, pharma, or CDMO sector.
- Experience contributing to business development, conference activity, or thought leadership.
- Willingness to represent the consultancy externally through industry events and LinkedIn.
What You'll Bring
The ideal candidate will be more than a technical regulatory writer. You will be someone who can combine deep CMC knowledge with commercial awareness and strong interpersonal skills.
You should be comfortable moving between reviewing a complex Module 3 section, joining a client call, discussing a regulatory strategy with a senior stakeholder, and representing the consultancy at an industry conference.
You will have the credibility to speak confidently with CMC, Regulatory, Manufacturing, Quality, and R&D professionals, while also being commercially minded enough to identify where the consultancy can add further value.
What We Offer
- Fully remote working within England or Belgium
- Full-time permanent position
- Opportunity to work across a diverse portfolio of biologics and advanced therapies
- Exposure to complex international regulatory programmes
- Combination of technical delivery, consulting, and business development
- Opportunity to build a strong external profile within the biopharma industry
- High degree of autonomy and flexibility
- Opportunity to play a key role in the continued growth of a specialist consultancy
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