Regulatory Manager: Edinburgh (Full-time)

Company Regulatory Professionals
Posted 1 Week, 3 Days ago
Address Edinburgh
Salary
Sector Healthcare & Medical
Type Full-time
Job Level Not Applicable

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Regulatory Affairs Manager

 

Scotland Commutable from Edinburgh

 

Regulatory Professionals are currently partnering with a global bio-pharmaceutical company, to assist them in their search for a Regulatory Affairs Manager. The position will focus on the supporting of regulatory EU activities, from the development of strategy to post licensing activities.

 

Key Responsibilities:

 

Represent regulatory affairs department at project team meetings for defined projects, providing information, feedback and strategic advice

 

Execution of the regulatory activities required by the terms of the marketing authorisations

 

Coordinate communications with regulatory authorities and internal stakeholders

 

EU post-licensing activities and development, including development of regulatory strategy

 

Regulatory activities for clinical trials, and regulatory activities associated with the maintenance of marketing authorisations including those required for novel products.

 

Experience Required

 

Life Science qualification

 

At least 5 years experience within Regulatory Affairs

 

Experience with a range of EU procedures such as paediatrics, orphan drugs would be preferable

 

EU pre and post-licensing regulatory experience in particular with centralised products

 

A self-starter, willing to learn and able to work collaboratively with various functional teams.