Regulatory Affairs Executive

5 days ago

Slabatpura Surat Gujarat, India Trident Lifeline Pvt. Ltd. Full time

**Job Summary**:
The Regulatory Affairs Executive will be responsible for ensuring that the company’s products comply with all regulations and guidelines of relevant regulatory authorities. The role involves preparing, compiling, and submitting regulatory documents, liaising with authorities, and maintaining regulatory compliance across domestic and international markets.

**Key Responsibilities**:

- Prepare, compile, review, and submit regulatory dossiers for domestic (DCGI, CDSCO) and international markets (e.g., WHO, EU, Africa, LATAM).
- Coordinate with R&D, QA, QC, and Production teams for documentation required for regulatory submissions.
- Maintain up-to-date knowledge of applicable regulatory requirements and ensure timely compliance.
- Handle queries from regulatory authorities and coordinate timely responses.
- Manage and maintain the regulatory database and filing systems.
- Assist in reviewing labeling, packaging, and promotional materials for compliance.
- Monitor changes in regulations and communicate updates internally.
- Participate in audits and inspections from regulatory bodies and partners.
- Support product launches by ensuring all regulatory approvals are in place.

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

Pay: ₹12,000.00 - ₹25,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Day shift
- Morning shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

Work Location: In person

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