Biocon- Requirement for Deputy Manager / Associate Manager-National Regulatory Affairs
Job Description
Extensive knowledge about Drugs & Cosmetic Act of India and NDCT Rules 2019. Leading and guiding the team members and imparting training to the team members to keep them abreast of the regulatory updates. Realistic experience & exposure with Indian Regulatory Authorities like CDSCO-HQ (DCGI),CDSCO Zonal & Sub zonal offices, State Licensing Authorities and RCGM/IBSC, GEAC, FSSAI & Testing Laboratories such as CDL & IPC. Planning, execution, review and timely submission of applications such as new drug, BA/BE, CT, Import/export applications; NOC for Test License, Import NOC for Dual Use items and NOC for Export, CoPP, WHO-GMP) and handle inquiries from Regulatory authorities related product approvals. Interact with various departments/teams (QA/QC/R&D/PM etc) to ensure filing of required regulatory documents on time as per regulatory norms.
Post Name : Deputy Manager / Associate Manager-National Regulatory Affairs
Qualification: M.Pharm/ M.Sc
Experience: 8-10 years
Location : Bengaluru
Vacancies: NA
Salary : Not Disclosed by Recruiter
Contact Details :
Company : Biocon Limited
