InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.  The company is also referred to as Cipla New York.

The Cipla New York site consists of three manufacturing facilities and a diverse workforce performing a variety of roles such as senior scientist, quality control chemist, quality assurance associate, regulatory affairs analyst, manufacturing and production operators, and other business and technical positions.

This position reports to the Director of Regulatory Affairs for the InvaGen Pharmaceuticals, Inc. business of Cipla.  

The incumbent selected for this position is expected to:

Write, critically review, evaluate, compile and publish FDA submissions (ANDAs, amendments, supplements, annual reports and additional documentation, as needed) in eCTD format. 

Development of product labeling, including package inserts and container labels, Medication Guides, for the review, approval, tracking and archiving and submission. 

Maintain controlled records of historical current and previous labeling changes, submit the relevant supplements. 

Reviewing Chemistry, Manufacturing, and Controls (CMC) and Good Manufacturing Practices (GMPs)  data for adequacy and conformance to regulatory requirements and acceptability of documents for submission.

Effective communication with other internal departments, external vendors and partners with the goal of achieving the shortest possible time from project inception to product launch and assure submission timelines are met.

Bachelors degree in Pharmacy or Chemistry combined with about 2 or more years of hands-on experience of ANDAs filings and other regulatory submissions with USFDA is required.  

Proficiency in applicable computer and database applications (i.e. MS Word, Ms Excel, PDF, eCTD submissions software, labeling design software etc.) as well as applicable knowledge in FDA regulations and FDA/ICH guidelines.  

All your information will be kept confidential according to EEO guidelines.