Company: CK Clinical
Closing Date: 09 Nov 16
Salary (£): Negotiable
Oliver Care is recruiting for a Senior Regulatory Affairs Manager, CMC to join a global pharmaceutical company committed to contributing to better healthcare at their...
Oliver Care is recruiting for a Senior Regulatory Affairs Manager, CMC to join a global pharmaceutical company committed to contributing to better healthcare at their site based in Hertfordshire on a permanent basis.
This is an excellent opportunity to join a global leader within their field, offering a competitive salary and benefits at an exciting time in their product development.
The main purpose of the role will be:
-To be responsible for assigned topics to meet high quality CMC writing or compilation to meet project key milestones and timings.
-Take-up regulatory accountability for the CMC aspects of the projects/products goals and objectives
-Provide oversight for the CMC components of all regulatory submissions (IND or CTA, NDA or MAA, amendments, variations, scientific advice briefing documents, CMC agency communications etc.) to ensure that quality documents are prepared in compliance with the applicable regulatory requirements.
-Engage or lead CMC sub-teams to plan, prepare and complete the CMC section of major submissions.
Further responsibilities will include:
-Leading effective responses to Health Agency CMC questions
-Engage in regional/national health agency meetings for CMC related discussions .
-Interacting with the external stakeholders regarding CMC regulatory issues
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level within a relevant field or equivalent experience
-Must have extensive regulatory experience
-Must have working knowledge of both the formulation and analytical aspects of R&D
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37293 in all correspondence.
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