Regulatory Manager

```html 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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