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Job Details

Senior Regulatory Affairs Manager - Cambridge

Company: Hobson Prior
Location: Cambridge
Reference: HS433479
Closing Date: 12 Nov 16
Type: Contract
Salary (£): On Application
Benefits: £60 - £80 per hour dependent on experience

Job Summary:

An opportunity has arisen to join the Global regulatory Team (GRT) in an international biopharmaceutical company in Cambridgeshire as a Senior Regulatory Affairs Manager on a 12 month contract.


 An opportunity has arisen to join the Global regulatory Team (GRT) in an international biopharmaceutical company in Cambridgeshire as a Senior Regulatory Affairs Manager on a 12 month contract.

The successful candidate will assist in developing and implementing regional regulatory strategies and managing agency interactions. The purpose of this role is to ensure that the client acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products, as well as to market approved medicinal products; and to ensure timely regulatory compliance with above approvals.


Responsibilities include but are not limited to:

·         Advising on and in some cases leading the development and implementation of regional regulatory strategy

·         Lead development of regional regulatory documents and meetings in line with GRT strategy

·         Direct the development of the regional product label by collaborating with the Labelling Working Group

·         Co-ordinates company responses to requests from regulatory authorities, e.g. Response to Questions (RTQs)

·         Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)


Skills and Experience


·         Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

·         Cultural awareness and sensitivity to achieve results across both regional country and

·         Emerging Markets Knowledge

·         PIP experience



·         Regulatory knowledge in regional legislation.

·         Working with policies, procedures and SOPs.

·         Experience with national legislation and regulations relating to medicinal products. Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.

·         Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes.

·         International borders.

·         Understanding of drug development.

·         Scientific / Technical Excellence.

·         Strong knowledge of and experience in regional regulatory environment in a product area and development stage.

·         EU centralised procedures knowledge and experience

·         Clinical Trials experience

·         5 years regulatory experience minimum


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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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