- Regulatory support and review for pre-filing and development documentation.
- Coordination with internal and external stakeholders for regulatory filing related documentation.
- Review, compilation and authoring of CMC, biopharmaceutics, labeling, module 1 document
- Review of plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc.
- Authoring, Compilation and review of ANDA dossier in eCTD format, followed by publishing, validation and submission of dossier
- Authoring, Compilation and review of Structure Product Labeling (SPL)
- Consulting, categorizing, authoring Post approval changes through appropriate supplements. Submission of annual reports on respective anniversary dates
- Participation in regulatory audits from US FDA and provide regulatory support
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