Senior Manager, Regulatory Affairs: Ensure preparation and submission of ANDAs, amendments, supplements, and annual reports to support commercial business. Ensure reports are in compliance with FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for FDA approval. Work cross-functionally with other sies and/ or CMOs, project management and R & D departments to ensure compliance and proper implementation of regulatory affairs related matters. REQ.: Bachelor's degree in Pharmacy, Pharmaceutical Science, or related field of study or foreign educational equivalent. Min. 5 years of regulatory experience in pharmaceutical industry is required with ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements. Submit resume & salary reqs.: hr.communication@sunpharma.com or by U.S. mail to HR Department, Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08501.
Required skills
- FDA Regulations Knowledge
- Pharmaceutical Experience