Regulatory Affairs Executive
7 days ago
**Licensing & Approvals**:
- Obtain product permissions from relevant regulatory authorities.
- Liaise with government agencies to ensure timely approvals and renewals
**Dossier Compilation**:
- Compile, review, and submit regulatory dossiers in **CTD (Common Technical Document)** and **ACTD (ASEAN Common Technical Document)** formats.
- Ensure documentation complies with national and international regulatory standards.
- Coordinate with internal departments to gather required technical and quality data.
**Artwork Compliance**:
- Review product artwork and labeling to ensure alignment with regulatory standards and country-specific requirements.
- Provide feedback and corrections to design teams to maintain compliance.
**Qualifications & Skills**:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field.
- 2-5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry.
- Strong understanding of regulatory guidelines (e.g., CDSCO, ASEAN).
- Proficiency in dossier preparation and submission processes.
- Excellent communication and documentation skills.
**Job Types**: Full-time, Permanent
Pay: ₹180,000.00 - ₹360,000.00 per year
**Benefits**:
- Health insurance
Work Location: In person
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