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Job Details

Regulatory Scientist

Company: SRG Clinical
Location: Harrow
Reference: J23124
Closing Date: 04 Dec 17
Type: Permanent
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 Regulatory Scientist- CMC on a permanent basis to be based at their offices in West London.

Requirements:

The Role
Submitting Marketing Authorisation applications of CP/DCP/MRP/National procedures & relevant activities across international markets including, UK, IE, EU, MENA and CIS regions.

Key Responsibilities/Requirements:

Review / Audit of dossiers for marketing authorizations;
Monitoring of the registration process (CP/DCP/MRP/National procedures)
Preparation/Verification of responses / variations documentation / notifications for CP/DCP/MRP/National procedures;
Submission of End of Procedure national phase documents for DCP/MRP procedures;
Obtaining MAA Renewals/Notifications;
Correspondence with regulatory authorities & other relevant agencies;
Maintaining files for product licenses;
Co-ordinating and submitting the new applications and post approval changes.
To offer assistance in compilation of dossier before submission to the agencies and to handle the validation phase and country specific requirements for the procedures with the aim of quick validation and procedure start.
To be a part of team and assist in documentation, archiving and communication to multiple departments the receipt of MA and variation details to ensure effective change implementation and compliance.

Skills/Experience Required:

Life Science Degree qualified
Extensive proven Regulatory experience with strong commercial awareness ideally in a Pharmaceutical/Manufacturing or a similar environment -maintaining post marketing maintenance.
Writing of CMC (module 2 and 3), Variations (Type 1A, Type 1B) and renewals
Experience of working with line management in the business with ability to influence, challenge and deliver change.
Ability to build relationships with people of all levels in the organisation and to use these relationships to deliver exceptional results.

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: Regulatory Scientist

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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