Dra -executive

5 days ago


Chandigarh Chandigarh, India Maya Biotech PVT LTD Full time

**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**

Pay: ₹35,000.00 - ₹40,000.00 per month

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



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