- Preparation of ANDAs and assistance for document review of all projects.
- Life cycle management of ANDAs (through Annual Reporting, Post approval supplements).
- Deficiency responses and labeling amendments.
- Timely submission of ANDAs, Annual reports & post approval variations.
- Ensuring accuracy and adequacy of the registration documents required for upcoming new ANDAs.
- Compilation of ANDA submission.
- Compilation and submission of CBE-0, CBE-30, PAS, Leading supplements, annual reports.
- Generation and submission of SPL for drug listing.
- Provides responses to queries received from US FDA.
- Review and comment on technical documents related to dossier compilation or query response.
- Maintaining department records as assigned.
- Co-ordination and communication with cross functional team members to ensure the submission within stipulated timeframe.
- Any other responsibility assigned by Head of the Department.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Unichem Laboratories Ltd
Recruiter Name:Samir Gaikwad
Contact Company:Unichem Laboratories Ltd