Company: CK Clinical
Closing Date: 31 Oct 16
Salary (£): Negotiable
Mary Tilston is recruiting for a Regulatory Expert to join a a highly established research-based pharmaceutical company at their site based in Switzerland on a...
Mary Tilston is recruiting for a Regulatory Expert to join a a highly established research-based pharmaceutical company at their site based in Switzerland on a 6 month contract basis.
The main purpose of the role will be to:
-Coordinate and prepare Active Substance Master Files, Drug Master Files and Certificate of Suitability Submissions for new submissions regular updates, variations and renewals.
-Communicate and collaborate with customers to develop and align regulatory filing strategies and implementation plans.
-Coordinate and prepare responses to deficiency letters, authority requests and customer requests related to filings and/or other regulatory/technical questions or questionnaires.
Further responsibilities will include:
-Regulatory assessment of change requests and development of the regulatory implementation plan as well as regulatory assessment of major non-conformances and regulatory consultation for Quality Assurance.
-Ensuring regulatory filing compliance and continued lifecycle management as well as providing regulatory support for inspections and audits.
-Partner with Global Regulatory groups to coordinate and ensure the submission of filings for US and/or other countries and partner with production, Chemical and Analytical Development, QC, QA and other departments as needed.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-Educated to degree level or above in life sciences or a related field with significant experience in a highly regulated environment.
-Experience in Regulatory CMC (Module 3) and drug development is preferred.
-Experience in developing regulatory strategies and the ability to communicate regulatory requirements as well as excellent communication skills.
-Knowledge of German would be beneficial but not essential.
This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.
CK Clinical is an Equal Opportunities employer who 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 CL37232 in all correspondence.
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