Knowledge of Intellectual Property policies in biologics and basic sciences, along with a sound understanding of biotechnology and molecular biology techniques.
Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.
Part of Indias Leadership Team, leads the strategic direction of marketing efforts within the local market, ensuring alignment with area and global objectives while driving business growth.
Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or new formula issues.
Provides support, consultancy and oversight on Quality Issues that occur across the organization during the performance of the services provided by both Clinical and Corporate
Ph.D / first class M.Sc Degree (Microbiology, Biotechnology, Life sciences and Pharmacology) from recognized institution with 5 years experience in molecular biology and microbiology.