Manager Regulatory Affairs at The Judge Group Inc. in Morristown, New Jersey

Job Description:

Location: Morristown, NJ

Description: Our client is currently seeking a Manager Regulatory Affairs

The Manager, Regulatory Affairs reports into the Director/Associate Director Regulatory Affairs and is based in Pine Brook, New Jersey. Manages team of 1-3 direct reports.


This job will have the following responsibilities:



Primary responsibilities of this role include the following:


Prepares and compiles new ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.


Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence.


Coaches & directs team to produce excellent work; provides development opportunities for team to reach their full potential.


Participates in the establishment of project plan due dates and ensure that the due dates for milestones are met.


Ensures that change management activities for existing commercial products are executed properly and on-time.


Interfaces with project team members and functional departmental representatives to obtain documentation and establish timelines to ensure that complete and accurate submissions are prepared according to plan.


Assists in promoting sound strategies in support of submission goals.


Participates in project team meetings and provides regulatory acumen to staff and internal team members in support of projects.



Qualifications & Requirements:



Minimum of 6 years in the pharmaceutical industry and a Bachelor's Degree in a life science -Or- 5 years in the pharmaceutical industry and a Master of Science (M.S.) in Regulatory Affairs or an equivalent advanced degree preferred 5 years in previous experience in Regulatory Affairs 1 years of supervisory/managerial experience preferred Prior experience in the Generics industry preferred



Contact: ktandukar@judge.com


This job and many more are available through The Judge Group. Find us on the web at www.judge.com