
Regulatory Affairs Executive
2 days ago
Job Title - Regulatory Affairs
Experience - 3 -5 years in finished doses form
Location - Pune
Industry - Leading Pharma Industry
Roles and Responsibilities
To coordinate and preparation of Quality Agreements.
Maintain the required documents for Regulatory Affairs.
Liaising with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.
To prepare SOPs for Regulatory Affairs, reviews the SOPs, MFR, BPCR, Change control, Deviation & CAPA.
To implement & maintain cGMP, QMS as applicable to Regulatory Affairs function.
Identify potential emergency situation in the department and provide the needed support to Department Head or HR. & Department, Head of Environment, Health and Safety in preparation of the Emergency Preparedness and Response plan.
Thanks and Kind Regards,
HR Department,
Pay: ₹600,000.00 - ₹850,000.00 per year
Schedule:
- Day shift
Ability to commute/relocate:
- Pune, Pune - 413802, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- FDA regulations: 4 years (preferred)
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