Job Summary:
The DRA Executive will be responsible for supporting regulatory submissions, compliance, and approvals for pharmaceutical products specifically for injectable pharmaceutical products, ensuring alignment with global and local regulatory requirements. The role involves coordination with cross-functional teams to ensure timely regulatory approvals and maintaining regulatory documentation.
Key Responsibilities:
- Prepare, compile, dossiers (CTD, eCTD) .
- Coordinate with R&D, QA, Production, and Marketing teams for regulatory compliance.
- Track and follow up on regulatory submissions and approvals.
- Maintain regulatory databases and document management systems.
- Assist in preparation of responses to regulatory queries.
Qualifications & Skills:
- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or related field.
- 4–5 years of regulatory affairs experience in injectable products is mandatory.
- Strong knowledge of Indian and global regulatory guidelines for injectable formulations.
- Strong documentation .
- Ability to work independently and coordinate with cross-functional teams.
Reporting: Reports to Manager – Regulatory Affairs
Job Type: Full-time
Ability to commute/relocate:
- Chandigarh, Chandigarh: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Injectable plant : 4 years (Required)
- DRA : 4 years (Required)
Work Location: In person
