Regulatory Affairs Manager

Job type:
permanent
Start:
06/2015
Duration:
n.a
From:
Real Staffing
Place:
Scotland
Date:
02/16/2015
Country:
flag_no United Kingdom

Project description:
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This project is archived and not active any more.
You will find vacant projects in our project database.
Regulatory Affairs Manager

Location: Scotland

Salary: Up to £58,000 circa + Package

Within this role you will be responsible for Post licensing /CMC regulatory activities associated with ensuring that all of our marketed products are in compliance with applicable legislation and business requirement.

Key Accountabilities will include:
* Compliance with relevant regulatory legislation and guidelines.
* Representation of regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice.
* Co-ordination of the regulatory activities associated with project team plans.
* Preparation, attendance and follow-up of meetings with Regulatory Agencies.
* Management of regulatory submissions, including applications for marketing authorisations.
* Co-ordinate the provision of information requested by regulatory authorities and communications between Post-Licensing Regulatory Affairs, Regulatory authorities, Licensing Partners and Affiliate Regulatory Affairs contacts.

You will have a sound knowledge of the CMC Regulatory Affairs arena yet relish the challenge of entering a role in which you can develop your expertise generally across the profession, by being involved in a spectrum of Regulatory activities.

If you are keen to apply please send your C.V to Natalie Hopkins at n.hopkins(a)realsttafing.com or call on