Senior Manager Of Regulatory Affairs

Excellent Senior Manager of regulatory affairs position is available in Bridgewater, New Jersey, seeking qualified candidates interested to progress their careers in an exciting pharmaceutical setting. Salary is extremely attractive at up to $135k+15% bonus and stock options yearly! Vacation is very attractive at 4 weeks with the Christmas to new year shut down!

Main Responsibilities:

- Participates in the development and implementation of regulatory strategy for new development programs
- Manage interactions with the FDA and other international regulatory agencies for assigned drug development programs
- Represent Regulatory Affairs on clinical study execution teams, clinical development teams, nonclinical development teams, and/or other cross functional teams
- Oversight and strategic direction across a number of clinical initiatives to ensure program harmonization
- Contribute to Clinical Study Report/IND/NDA documentation as needed
- Review of abstracts, presentations, and other publications
- Addresses complex issues and problems providing innovative solutions and guidance to the team
- Manages multiple and changing priorities on a daily basis
- Prepares presentations for cross-functional audiences, with supervision

Required Skills and Experience:
-MS or BS of scientific background
- Experience preparing, submitting, and successfully opening an INDwith the FDA
- Experience preparing, submitting, and successfully gaining approval for CTAs inCanada and/orEurope
-5-10 years of regulatory affairs experience

Candidates are encouraged to apply if you have excellent NDA/IND experience! I also have other positions in regulatory affairs eagerly seeking local New Jersey candidates!

Send in your resume today at 212-707-8499! Please contact Dandan Zhu at Real Pharma!To find out more about Real Staffing please visit www.realstaffing.com