Senior Regulatory Associate - Emerging Markets

Date Posted: Thursday, 9th of February 2012

Salary: £35,000 - £40,000

Start Date: ASAP

Telephone: 01438 870024

Location: Bucks

Discipline:Regulatory Affairs

Consultant Name: Meera Pattni

Sector: Pharmaceutical

Description

Senior Regulatory Associate - Emerging Markets

Job summary:
Support the implementation of regulatory operational activities in Emerging Markets in Europe, Middle East and Africa, and provide regulatory support for the registration and maintenance of activities of medicinal products. You will also be required to develop and maintain knowledge of regulatory procedures in the region.

Main responsibilities:
New Product Registration:
Ensure effective implementation of the assembly and preparation of core files for Marketing Authorisation Applications.
Work cross functionally to respond to questions from regulatory authorities to gain product approvals.
Ensure effective planning and tracking of activities.
Ensure effective coordination of the review and approval product related packaging as required, to ensure regulatory compliance.
Support the definition and communication of regulatory strategy in support of new product registration, in line with commercial activities.
Ensure that teams and functional groups are provided with clear, constructive regulatory advice and guidance.

Marketed Product Maintenance:
Provide regulatory support for assigned products and inputs to project teams via Global Regulatory Teams.
Ensure effective implementation of variations and renewals for the region.
Implement regulatory activities in support of lifecycle management and maintenance of the region.
Work with regulatory staff “in country"to support the markets.
Provide clear communication to “in country” and global regulatory staff on planned activities and priorities.

Person specification:
Life sciences degree.
Knowledge of international pharmaceutical regulations^and guidelines.
Extensive regulatory affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Europe.
Excellent organisation, planning and negotiation skills.
Excellent verbal and written communication skills.
Good interpersonal skills.
Ability to work collaboratively.

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 CL23685 in all correspondence.

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