Plans and coordinates activities to ensure regulatory lifecycle management activities and approvals are achieved by the Local Operating Company in a timely manner for all globally approved products.
Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Globally renowned, vertically integrated pharmaceutical player engaged in Research and Development (R&D), manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas.
Can handle instrument i.e HPLC- Dissolution 3C, IR,UV, QC QMS, Material testing xposure on EM, water testing, MLT testing of FP and RM/Stability samples , Analysis and review of Micro samples, reports.
Exposure of handling and compliance of various compression, coating and granulation machines, equipment Online documentation of BMR and log books during execution of batches.
M.Pharm, Pharm.D, BDS Postgraduate in registered life Sciences. Min 2 - 4 years relevant experience into Pharmacovigilance case processing and related activities in alignment with patient safety operations.
Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management. Allocation of projects to regulatory associate & manage the team for all the regulatory submission activities
Gufic Group have been in the Pharmaceutical industry since 1970 and are known and respected for Innovative and high Quality pharmaceutical and Herbal Products along with a wide range of APIs Gufic