Walker Cole International is supporting a growing international regulatory consultancy in the search for a Principal Consultant – CMC (Small Molecules).
This is an opportunity to join a highly respected consulting environment, supporting pharmaceutical and biotechnology companies with complex global development programmes. The role combines strategic regulatory advisory work, CMC leadership, client engagement, and team development.
You will play a key role in shaping regulatory and development strategies for innovative products, leading high-value client projects, mentoring consultants, and supporting the growth of a rapidly expanding business.
Key Responsibilities
* Provide strategic and technical regulatory advice to clients, with a focus on small molecule CMC development.
* Lead the development of regulatory strategies, drug development plans, and data gap analyses across global markets.
* Author and review key regulatory documentation including INDs, IMPDs, MAAs, scientific advice, and briefing materials.
* Represent clients in interactions with regulatory authorities and provide solutions to agency queries and objections.
About You
* MSc, PhD, PharmD or equivalent in a Life Sciences discipline
* Proven experience in CMC development and regulatory strategy for small molecule pharmaceuticals, including novel chemical entities (NCEs)
* Strong expertise across pharmaceutical development, manufacturing, and CMC regulatory requirements, with a solid understanding of FDA, EMA, ICH and GMP expectations
* Proven experience supporting global regulatory submissions and health authority interactions, including FDA and/or EMA/MHRA procedures
* Track record of developing and executing CMC strategies from early-stage development through to marketing authorisation
* Experience working across multiple dosage forms and complex development programmes
* Strong scientific leadership skills with the ability to mentor colleagues, lead client engagements, and influence senior stakeholders
* Consultancy experience is highly desirable, or alternatively a strong client-facing mindset and ability to build trusted relationships
* Excellent communication and presentation skills, with the confidence to represent clients in front of regulatory authorities and executive-level stakeholders
CMC / Regulatory Affairs / Small Molecules / Pharmaceutical Development / IND / IMPD / CTA / NDA / MAA / FDA / EMA / GMP / ICH / Regulatory Consulting / Drug Development / CMC Strategy / Principal Consultant
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