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Job Details

CMC Regulatory Compliance Specialist

Company: MSI Group Limited
Location:
Reference: VR0182
Closing Date: 01 Oct 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

CMC Regulatory Contract position - great hourly rate

Requirements:

·         Globally recognised pharmaceutical company

·         Competitive hourly rate

Our client is actively searching for a skilled professional to fill the role of CMC Regulatory Compliance Specialist. The successful incumbent will be responsible for ensuring accuracy of BE operational documents requested for filling in the time frame required.

Key Responsibilities:

·         Review and Approve, on behalf of Operations, files submitted to Health Authorities.

·         Represent the site at the Submission Team led by GRA.

·         Contribute to Key Message Summary (KMS) preparation.

·         Coordinate Questions & Answers and Commitments.

·         Provide technical/site support to Global Regulatory Affairs (GRA) in communication to and from Health Authorities.

·         Act as liaison between GRA and the site on regulatory compliance matters in the scope of new buildings submission.

Skills/Education Required:

·         Master degree or PhD Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline

·         5-7 years in Pharmaceutical industry,

·         Experience in a quality or regulatory compliance role (preferably in an FDA approved context)

·         Knowledge of quality systems and lean culture spirit

·         Capacity to work in cross functional teams and communication and influence skills

CMC, Regulatory, Submissions, Compliance, BE operations, Pharmaceuticals

Apply for this job: CMC Regulatory Compliance Specialist

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
SE1 1QL
England
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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