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Posted on 30 Nov, -0001
- Industry - PHARMACEUTICAL / MEDICAL DEVICES / CRO
- Functional Area - Regulatory Affairs / Corporate Affairs
- Job Role - Officer / Executive - Regulatory Affairs
- Employment type - Full Time
- Work Mode - In Office
- Managing regulatory affairs of the organization its subsidiaries / associates.
- liasoning with regulatory bodies like State and Central FDA, DCI, etc.
- Well conversant with Drug law/feed supplement regulation.
- Co-ordination with factory, purchase department, marketing department.
- Reviewing of technical documents like process validation, stability, etc.
- Compilation of dossiers and handling dossier related queries.
- Arranging and checking artworks for registration as per guidelines.
- Compilation and preparation of tender documents.
- Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
- To Audit sites to verify the executed documents (Process validation Protocol and reports and BMRs/BPRs) and its accuracy and readiness as per GDP and GMP norms.
- To maintain Data Bank for Commercial activity.
- To work with quality standards and adherence to system
- Excellent communication skills both written and verbal.
- Candidate will be responsible for Preparation of Dossiers.
- Candidate will be responsible for Compliance to queries received for dossiers submitted.
- Candidate will be responsible for Coordination with Plant QA & R&D for documentation.Candidate will be responsible for Artwork Checking .
- B.Pharma - Any Specialization
- MPharma - Any Specialization
- Any Doctorate - Any Specialization
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