Regulatory Manager

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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

• Preferably worked previously in CSSCO or DCGI

Required Skills

• Extensive knowledge of regulatory affairs
• Experience with audits and compliance

Preferred Skills

• Personal rapport in DCGI
• Previous experience in CSSCO or DCGI

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