1. Liaison with CDSCO(Central Drug Standard Control Organization) as well as local FDA & State Authorities for the Registration, licensing, NOC's for the approved products / bulk drug (API's).
2. Regulatory expertise in handling of worldwide Regulatory procedures followed by LATAM, ASEAN and ROW Countries.
3. Responsible for Regulatory Liaisoning Activities for India.
4. Handling various queries received from Regulatory Authorities and sent reply as per timelines.
5. To renew the licenses from the Centre as well as State for the expired licenses of specific products / bulk drug.
6. To file new licences for specified products & get the approval from Central & State Govt.
7.Coordination with plant QA, QC, production, ARD, CRD and IP for timely catering to document to DRA department for new submission, updates, customer/agencies.
8. Timely submission of documents and response to marketing department for the customer development.
9. Evaluation of changes (process, facility, batch size and analytical documents), their impact on Regulatory filings.
10. Act as primary regulatory representative at internal meetings as well as at meetings with business partners and regulatory clients for all issues.
11.Review Product Permission/Licenses, COPPs, FSC & Follow up with State FDA for taking approval.
Salary: INR 8,00,000 - 14,00,000 P.A.
Industry: Pharma / Biotech / Clinical Research
Functional Area: Legal, Regulatory, Intellectual Property
Role Category: Drug
Role: Regulatory Affairs Manager
Employment Type: Permanent Job, Full Time