Development & Regulatory Chemist
28 days ago
Hitchin
Exciting Opportunity: Development & Regulatory Chemist (APIs) Are you an analytical development chemist with strong regulatory writing skills and experience supporting API submissions? This organisation is seeking a Development & Regulatory Chemist to join its technical team, playing a key role in API development, analytical method validation, and regulatory documentation for pharmaceutical markets. Job Title: Development & Regulatory Chemist Vacancy Type: Permanent Location: Hertfordshire Salary: DOE About the Organisation You’ll be joining a specialist pharmaceutical ingredients business supplying regulated markets across the UK, EU and internationally. The organisation operates within a GMP‑aligned environment and works closely with pharmaceutical customers, contract manufacturers, and regulatory authorities to support API development and lifecycle management. The R&D and Technical function is responsible for analytical development, regulatory strategy, and maintaining high‑quality documentation to support existing and new API registrations. The team combines hands‑on scientific work with high‑impact regulatory authorship, making this an ideal role for a chemist who enjoys working across both laboratory and desk‑based technical activities. The Role of the Development & Regulatory Chemist This is a broad technical role focused on API development and regulatory support. You will contribute across analytical method development, validation, and regulatory documentation, with a key responsibility for ASMF authoring and lifecycle maintenance. Working closely with the Technical Manager and cross‑functional teams, you’ll support both existing product portfolios and new API introductions. Key responsibilities include: • Supporting the development and characterisation of pharmaceutical active ingredients (APIs), • Developing, validating, and transferring analytical methods in line with ICH and GMP expectations, • Authoring, maintaining, and updating Active Substance Master Files (ASMFs), • Preparing high‑quality technical documentation suitable for direct regulatory submission, • Managing analytical method transfer to internal QC and external contract manufacturers, • Supporting regulatory submissions, variations, and responses to authority questions, • Coordinating analytical work with external laboratories and manufacturing partners, • Overseeing analytical activities at pilot through to commercial scale, • Writing and reviewing technical reports, SOPs, and development documentation, • Providing technical input to commercial and customer discussions when required, • Supporting lifecycle management of registered APIs and ensuring ongoing regulatory compliance The Ideal Candidate for the Development & Regulatory Chemist Role To succeed in this role, you will bring: • At least 3 years’ of recent experience in pharmaceutical analytical development of APIs, • Proven experience authoring and maintaining ASMF documentation, • Strong understanding of analytical method validation in accordance with ICH guidelines, • Experience supporting regulatory submissions for active substances, • Excellent technical writing skills with the ability to produce regulator‑ready documentation, • A methodical, organised approach with the ability to manage multiple technical priorities, • Strong communication skills and confidence working cross‑functionally Why This Role? This is an excellent opportunity for a chemist who wants meaningful involvement in both analytical development and regulatory strategy. The role offers clear technical ownership, deep exposure to ASMF preparation and lifecycle management, and the opportunity to play a key role in supporting API registrations across global pharmaceutical markets. SRG are the UK’s number one recruitment company specialising in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals and medical devices sectors. As scientists ourselves, our specialist sector knowledge and passion are second to none. We’re committed to providing outstanding temporary, contract and permanent career opportunities at all levels. If this role isn’t quite right, feel free to get in touch or visit www.srgtalent.com to view our other vacancies.
