Regulatory Affairs Executive

2 days ago


Pune, India Salahkaar consultants Full time

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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