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Job Details

Dossier Conformance Manager

Company: SRG Clinical
Location: Surrey
Reference: J23583
Closing Date: 12 Oct 17
Type: Part Time
Salary (£): Negotiable
Benefits:

Job Summary:

My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and are looking to recruit a European Dossier Conformance Associate- on an initial 12 Month contract basis to be based at their offices in Surrey.

Requirements:

The Role:

Perform conformance assessment between manufacturing documents and in-market dossiers filed with Europe and Emerging Markets Europe local Health Authorities, focusing on Module 3.

Committed to quality and excellence in compliance and conformance.



Key Responsibilities/Requirements:


Data collection and evaluation in preparation for product and market assessment.

Perform conformance analysis of source dossier with market dossier

Ensure compliance systems accurately reflect market approval and manufacturing practices

Operate to the highest conformance standards

Operate in line with internal SOPs and policies

Liaise with regulatory colleagues to communicate and resolve potential issues



Skills/Experience Required:


Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.

Experience in a Regulatory or compliance role within the pharmaceutical industry.

Strong compliance focus and understanding Good knowledge of content and requirements for CTD Module 3 Attention to detail.

Demonstrated experience with a pharmaceutical company with proven examples of contribution.

Knowledge and understanding of quality systems, processes, audit and inspection

Experience with maintaining electronic systems and databases

Knowledge on general standards, processes and policies of Pharmaceutical manufacturing Industry



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.

Apply for this job: Dossier Conformance Manager

Contact Information:

Address:  Head Office
SRG Clinical 9 Devonshire Square London United Kingdom
EC2M 4HP
England
Tel:  +44 (0)203 096 4700
Website:  Visit Our Web Site

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