Regulatory Affairs Executive

2 weeks ago

Ahmedabad Gujarat, India WEST-COAST PHARMACEUTICAL WORKS LTD Full time

**Job Title**: Regulatory Affairs Executive

**Department**: Regulatory Affairs (RA)

**Location**: Sola, Ahmedabad

**Job Summary**:
**Key Responsibilities**:

- **Preparation and Compilation**:

- Prepare registration dossiers in CTD, ACTD, or country-specific formats as per regulatory requirements.
- Arrange and organize registration documents according to country-specific guidelines.
- **Review and Approval**:

- Review and approve registration documents prepared by assistants.
- Check, verify, and approve documents received from the Quality Control (QC) and Quality Assurance (QA) departments for dossier compilation.
- Review and approve nonclinical and clinical documents, SPCs, PILs, Pack Inserts, and PSURs for dossier compilation.
- Verify and approve artwork of packaging materials for both domestic and export markets.
- **Coordination and Follow-Up**:

- Conduct daily follow-ups with various departments to ensure timely receipt of required dossier documents.

**Qualifications and Skills**:

- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or a related field.
- Minimum 0-3 years] of experience in regulatory affairs or a related role.
- Proficiency in preparing dossiers in CTD/ACTD formats and country-specific requirements.
- Strong knowledge of regulatory guidelines and documentation processes.
- Excellent organizational, communication, and analytical skills.
- Attention to detail and ability to work under tight deadlines.

Pay: Up to ₹360,000.00 per year

Schedule:

- Day shift

Supplemental Pay:

- Performance bonus

Work Location: In person

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