Description
About the company
A growing international regulatory and product development consultancy is looking to appoint a senior CMC leader to support global pharmaceutical and biotech clients. The business works across development strategy, regulatory delivery and technical problem-solving, with a strong reputation for helping clients move products through development efficiently and with fewer regulatory risks.
This opportunity would suit someone who enjoys high-level scientific consulting, direct client ownership and the chance to influence both project delivery and team development. The position is hybrid in the UK and offers the chance to work with a respected international team supporting complex development programmes across multiple markets.
Responsibilities
- Act as the senior CMC adviser for small molecule development programmes, providing strategic, technical and regulatory guidance across the product lifecycle.
- Build practical development plans, identify data gaps and shape regulatory strategies that support progress from early development through to approval and post-approval lifecycle activities.
- Lead and review core development and regulatory documentation, including materials used for clinical submissions, health authority interactions and marketing applications.
- Guide clients through agency questions, objections and meeting preparation, acting as a credible technical partner during critical decision points.
- Manage multi-country consulting projects, keeping delivery on track against timelines, scope and budget.
- Support and mentor junior team members, helping raise technical capability across the wider group.
- Contribute to commercial growth by supporting business development discussions and building deeper relationships with existing clients.
Requirements
- Strong scientific background, ideally with an advanced degree in a life science, pharmaceutical science, chemistry or related discipline.
- Significant experience in CMC strategy for small molecule products, with deep understanding of development, manufacturing and regulatory compliance.
- Proven track record supporting programmes across the full CMC lifecycle, from early-stage development to registration and lifecycle management.
- Solid experience working with major regulatory frameworks and authorities such as FDA, EMA, MHRA, ICH and GMP requirements.
- Confidence authoring, reviewing and defending complex regulatory and development documentation.
- Ability to lead senior client conversations, solve technical problems commercially and represent projects with authority.
- Previous people leadership, mentoring or team development experience.
- Comfortable working in a consulting environment where client delivery, technical quality and business growth all matter.
Apply
This role is suited to a senior CMC professional who wants broader influence than a typical in-house position can offer. It is likely to appeal to Principal Consultants already in consulting, or Director level and Senior Director level CMC leaders from pharma or biotech who want to move into a more strategic and externally facing role.
For a confidential discussion, get in touch with Stirling Q&R with a copy of your CV. All conversations will be handled discreetly.