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.


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.


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