Regulatory CMC Specialist

Recruiter
SRG Clinical
Location
Northumberland
Posted
08 Feb 2018
Closes
16 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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 589673The 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.

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