Biological E Ltd is a leading global vaccine & pharmaceutical company which provides affordable immunization and medicines across the world. It has current turnover of around 1000 Cr and having employee strength of around 2000, growing at around 36% CAGR. Their intellectual pool of experienced scientist are based out of India and France.
Job Title: Executive/Deputy Manager Regulatory Affairs
No.of Openings: 2
Eligibility: B.Sc/ M.Sc/ B.Tech/ M.Tech Bio-Chemistry, Microbiology, Biotechnology
Experience: 2 - 7 yrs
Job Description:
Responsible for compilation and submission for various approvals related to NRA, WHO
DCGI: Compilation and submission of dossiers for approval from central licensing authority
State DCA: Support compilation of technical data for grant/renewal of various license/approval
Provide regulatory impact assessment for proposed changes
Preparation and submission of post approval change application to NRA
RCGM: Compilation, submission of applications for permission from RCGM
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