Senior Manager Regulatory Labeling

Senior Manager Regulatory Labeling

Job Title: Senior Manager Regulatory Labeling
Contract Type: Contract
Location: New York, New York
Salary: Negotiable
Start Date: ASAP
Reference: ac1099
Contact Name: Andrew Carr
Contact Email:
Job Published: December 05, 2016 21:41

Job Description

The role is wide ranging with a remit to support both pre and post approval labelling activities as well as supporting the compliance with internal SOP's and external regulations including submissions to external regulatory agencies.

Key responsibilities will include:

Supporting the development, implementation and the maintenance of CCDS and global package inserts. This will include USPI and SmPC to support regulatory submissions.

Supporting the development of systems and processes.

Supporting the review of labelling sections of NDA annual reports

Tracking of CCDS updates

Maintaining up to date with knowledge of regulations, policies and laws of FDA, EMA and other applicable regulatory agencies.

Experience required:

Minimum Bachelors in related field

Minimum of 5 years regulatory experience

Minimum of 2 years regulatory labelling experience

For an opportunity to discuss this unique opportunity in more detail please contact Andrew Carr at or 646 810 3847