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Job Details

Associate Director, Regulatory Affairs

Company: only medics recruitment ltd
Location:
Reference: JO-1901-422415
Closing Date: 18 Feb 19
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

Our client is a fast growing clinical stage biotechnology business which is making great strides in combating some of the most difficult neurological diseases afflicting children.

Requirements:

Our client is a fast growing clinical stage biotechnology business which is making great strides in combating some of the most difficult neurological diseases afflicting children.

They have an Associate Director, Global Labeling role based at their R&D center near Princeton New Jersey.

-Leads efforts to create, modify, and review labeling documents, including core data sheet, prescribing information, patient labeling, and packaging/artwork content for use with attention to competitive positioning
-Co-ordinates response to labeling-related questions from authorities and convenes labeling working group meetings to reach content consensus with technical experts
-Prepares presentations and trains other departments and outside speakers
-Responsive to business goals offering creative and compliant solutions while ensuring absolute regulatory integrity and consistency in labeling activities and communications
-Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial team members during labeling development and reviews
-Provides upon request analysis of competitor labeling in the relevant therapeutic area
-Responsible for continuous quality and compliance throughout the packaging labeling process
-Member on project teams and regulatory sub-teams, as appropriate
-Contribute to the development and implementation of Corporate and Department procedures and policies for the development of labeling.

For more information on this role please CLICK APPLY and forward a resume.

This company is an award winning, innovative business which is making very positive headlines and in a very strong position to grow over the next few years. This role will include a good salary and bonus package and stock options alongside standard benefits.

Apply for this job: Associate Director, Regulatory Affairs

Contact Information:

Address:  Head Office
3rd Floor, 33 Blagrave Street, Reading
RG1 1PW
England
Tel:  +44 (0)1189 522 799
Fax:  +44 (0)1189 560 607
Website:  Visit Our Web Site

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