[Close] 

Sr. Regulatory Affairs Associate

Job Req # 573979


Global Pharmaceutical Company is looking for:


POSITION: Sr. Regulatory Affairs Associate


SALARY:? $90-110k + Bonus


LOCATION:? West Caldwell, New Jersey


DEGREE: Required??


EXPERIENCE:? 5+ Years experience in Pharmaceutical regulatory affairs with Generics including writing ANDA, NDA, and INDs


SPONSORSHIP: No Sponsorship Available / No H1B


RELOCATION:? Assistance Available in the form of a Lump Sum


Must have experience writing part of an ANDA, NDA submission.


The Regulatory Affairs Associate, with minimal guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include ANDAs, amendments, supplements, annual reports and additional documents as needed. -Compiles and reviews ANDAs, amendments, supplements, annual reports, control documents, etc., for FDA submissions. -Interacts effectively with functional business units in order to coordinate facilitate documentation required for submissions, ensuring that departmental timelines are met.


Additional Responsibilities:


Coaches and mentors other associates. Trains less senior associates to review change requests and provides guidance to other associates in the preparation of other FDA submissions.


Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.


Interacts with FDA and all sites via written and phone communications.


Other duties, as assigned, or as business needs require.


Timely submissions and expeditious approvals.


Maintains compliance with regulatory requirements for generic drugs for the US market.


Assists in developing less senior associates into fully contributing staff.


Qualifications


BS in a scientific discipline or equivalent education and related experience


Minimum of five years in a Regulatory Affairs pharmaceutical environment.? Additional experience with Analytical, QA, R&D or production experience preferred.


Possesses strong critical and logical thinking.


Demonstrates thorough knowledge of all FDA requirements pertaining to submission of regulatory documents.


Demonstrates excellent organization skills and the ability to multi-task; detail oriented.


Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts


Demonstrates excellent verbal and written communication skills.


Shares concepts, ideas, information, and suggestions with management, peers and others.


Demonstrates the ability to evaluate regulatory documents and determine appropriate action.


Demonstrates the ability to provide regulatory assessment to other departments with little or no supervision.


Demonstrates the ability to coordinate submissions independently in a time intensive situation.


 

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Sr. Regulatory Affairs Associate
Princeton, NJ Kaztronix
Senior Regulatory Affairs Associate
Florham Park, NJ Shionogi
Sr Regulatory Affairs Specialist
Mahwah, NJ The Judge Group
Regulatory Affairs Associate
Princeton, NJ Kaztronix
Sr.Regulatory Affairs Specialist
Franklin Lakes, NJ BD (Becton, Dickinson and Company)