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Development & Regulatory Chemist

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SRG

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Location:
United Kingdom , Hitchin

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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 Responsibility:

  • 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

Requirements:

  • 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

Additional Information:

Job Posted:
May 05, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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