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
Monday, February 15, 2010
MANAGER/SENIOR MANAGER, REGULATORY AFFAIRS
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