Job Description Summary
Person will responsible for Compilation/ review of supplements ( including Injectable and OSD dosage form) ,Global Annula reports, preparation of summary documents for regulatory submission
Job Description
- Preparation, Review and Submission of Amendments and supplements for the assigned products
- Prepation of Summary documents for Regulatory submisison
- Preparation, Review and Submission of response to the Agency's queries for the assigned products
- Compilation and submission of Global Annual Report.
- Review of stability protocols and reports, analytical method validation protocols and reports.
- Review of raw material, packaging material, finished product specifications, finished product stability specification and testing procedure.
- Review of batch records.
- Review of Process Validation Protocol, hold time study protocols and Repots
- Review of Product Development Report
- Review of executed documents including executed BMR, Certificate of Analysis to ensure the compliance with regulatory requirement
Commitment To Diversity, Equity, And Inclusion
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
