Regulatory CMC Specialist

Job Ref: J25756
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 06 March 2018
  • Alnwick, Northumberland, England, UK
  • Competitive
  • Neal Panting
  • 01753 589601

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The Role:To produce CMC regulatory documentation and manage assigned CMC projects.Key Responsibilities:* To coordinate, produce and review early clinical phase CMC regulatory documentation for submission to global regulatory agencies.* To act as project manager and client point of contact, for assigned CMC projects.* Participate in discussions with potential clients and assist in the preparation of regulatory documentation related work proposals* Prepare and assist in the preparation of selected CMC documentation types such as release monographs.* Provide API and drug product related CMC regulatory advice to colleagues and clients.* Work with due regard to health and safety of self and others.* Work flexibly across the site to meet business needs.Skills/Experience Required:* BSc level qualified (Life Sciences) * Experience producing CMC regulatory documentation* Previous project management experience would be advantageous.* Excellent interpersonal skills, a good knowledge of early phase, small molecule, CMC regulatory requirements and familiarity with early phase drug development requirements.If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.