Description
Regulatory Affairs ManagerLocation: 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