Job Description
- Compile, prepare, review and submit ANDA submissions and Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible.
- Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
- Must have expertise/prior experience in Sterile (Injectables/Ophthalmic) dosage form ANDAs.
- Review / prepare documents which meet the requirement set forth by US FDA and accepted for review by FDA without query or RTR.
- Evaluate change controls and formulates strategies for correct filing categories, with guidance from supervisor. Proactively raises major project issues if any to superior for resolution and agreement. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS as and when necessary.
- Work very closely with all relevant departments at the time of product initiations, R&D phase, ANDA/Bio Execution and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.
- Prepare and finalize controlled correspondence to FDA on specific issues as needed for assigned projects.
- Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency.
Qualifications
M. Pharm
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
