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Monday, February 15, 2010

MANAGER/SENIOR MANAGER, REGULATORY AFFAIRS

Tris Pharma, Inc. (www.trispharma.com) a central New Jersey based specialty pharmaceutical company is focused on complex and difficult-to-formulate drug delivery products. Tris Pharma has an immediate opening for a Manager/Senior Manager of Regulatory Affairs for experienced and hands-on candidates with pharmaceutical submissions (ANDA, IND or NDA/505(b)(2)) background. Tris has currently completed development stages under INDs and plans to submit several NDAs/505 (b)(2) applications in 2010. The ideal candidate should have the following attributes, with a strong emphasis on drafting/supervision of clinical and non-clinical study reports, labels, interfacing with the Agency in both CDER and OGD environment, and ability to drive outcomes:

· BS/MS Degree (Life Sciences) with 7+ years experience in regulatory submissions including electronic submission eCTD, Gateway, and labeling submission (word, pdf, SPL, side-by-side), etc.

· Ability to lead effectively both generic and brand (Rx and OTC) projects in conjunction with internal and external teams including marketing to ensure timely approval and support launch of product

· Effective Project Management for internal and external teams consisting of CRO, clients, regulatory consultants, lawyers, and development scientists

· Knowledge of clinical trials, timelines, reporting, and FDA communications

· Supervise a growing team of regulatory affairs associates with the goal of meeting timelines, maintain effective compliance and coach/mentor the subordinates

· Interact and participate at management level to achieve overall regulatory goals



This is a highly visible, important position and offers an excellent compensation and benefits package. Tris Pharma, Inc. is an Equal Opportunity Employer.



To apply send resume and a cover letter via email to careers@trispharma.com or to



Tris Pharma, Inc.

Attn: Human Recourses - RA/MG

2033 Route 130, Suite D

Monmouth Junction, NJ 08852

or fax: 732-940-2855

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