Regulatory Manager
EYEGLOBAL SOLUTIONS PVT. LTD.Mumbai, Maharashtra, India19 hours ago
Job descriptionPreferably worked previously in CSSCO or DCGI Extensive knowledge of regulatory affairs Experience with audits and compliance Personal rapport in DCGI Previous experience in CSSCO or DCGI
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About the Company
Regulatory affairs in a biotech / biopharma company with knowledge of drugs and cosmetics act, GMP, Schedule M and having worked extensively in CDSCO, Local FDA, DCGI, RCGM.
About the Role
Must have faced multiple audits by these agencies. He / she must have experience in filing for all types of application including animal studies, clinical trials, marketing authorizations, manufacturing licenses, export and import licenses, GMP certification etc.
Responsibilities
- Knowledge of drugs and cosmetics act
- GMP and Schedule M compliance
- Experience with CDSCO, Local FDA, DCGI, RCGM
- Faced multiple audits by regulatory agencies
- Filing for all types of applications
- Animal studies and clinical trials
- Marketing authorizations and manufacturing licenses
- Export and import licenses
- GMP certification
- Personal rapport in DCGI
Qualifications
Required Skills
Preferred Skills
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Regulatory Manager • Mumbai, Maharashtra, India