Regulatory Affairs Executive

6 months ago


Pune, India Statistical Pharma Full time

**Main Duties and Responsibilities**
- Work closely with the supplier/manufacturer and regulatory authorities/bodies regarding product submissions and compliance.
- Prepare product technical dossiers for regulatory submission for both new products and existing product’s variation.
- Liaise with relevant parties to resolve product registration and regulatory issues.
- Ensure all required procedures and documentation for product variation/new product registration are promptly performed.
- Notify and update Health Science Authority (HSA) of any change of particulars/documents related to product registration on a timely manner.
- Maintain document control of technical file, quality procedures and work instructions for the purpose of product registration and to support audits.
- Keep track of changes in country’s regulatory requirements and provide regulatory intelligence to management and Business Development and Sales team.
- Support in the maintenance of the Quality Management System to comply with GMP/GDP requirements and international regulatory requirements.
- Maintenance of HAS importer license, wholesale license and other licenses for business operation.
- Oversee Pharmacovigilance - reporting of adverse reaction, adverse event and post marketing related activities to product owner and regulatory authorities.
- Any other ad-hoc duties as and when assigned by immediate Reporting Officer

**Job Types**: Full-time, Permanent, Fresher

**Salary**: ₹25,000.00 - ₹60,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund
- Work from home

Schedule:

- Day shift
- Morning shift
- Rotational shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

Work Location: In person



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