Regulatory Manager: Edinburgh (Full-time)

Company Regulatory Professionals
Posted 7 Months, 2 Weeks ago
Address Edinburgh
Sector Healthcare & Medical
Type Full-time
Job Level Not Applicable

Contact Employer

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.