Job Description

Key Responsibilities1. Regulatory Submissions

Prepare, compile, and submit

dossiers, CTDs/eCTDs, ANDA/NDA

, site registrations, and renewals. File applications for

product approvals, variations, stability updates

, and post-approval changes. Assist in obtaining and maintaining necessary

licenses, NOCs, and approvals

from regulatory bodies (e.g., CDSCO, FDA, EMA, WHO).

2. Documentation & Compliance

Review and validate

labels, artwork, product inserts, and packaging content

to ensure regulatory compliance. Prepare and maintain

Product Information Files (PIFs)

, technical documents, master formulas, and SOPs. Ensure documents meet

Good Manufacturing Practices (GMP)

and

Good Documentation Practices (GDP)

.

3. Coordination With Internal Teams

Work closely with

R&D, QA/QC, Production, Packaging, Marketing, and Supply Chain

teams. Facilitate smooth communication for data requirements, stability reports, COAs, and specifications.

4. Liaison With Regulatory Authorities

Communicate with regulatory bodies for clarifications, deficiency responses, and queries. Track status of submissions and ensure timely follow-ups and approvals.

5. Change Control & Risk Management

Manage regulatory impact assessments for formulation, packaging, or process changes. Support audit readiness for

regulatory inspections

and

quality audits

.

6. International Market Registration (If applicable)

Prepare dossiers for

ROW markets

, semi-regulated and regulated markets. Stay updated on country-specific guidelines and regulatory requirements.

7. Monitoring Laws, Guidelines & Updates

Keep track of changes in

drug regulations, pharmacovigilance rules, and documentation standards

. Update internal teams about new regulatory requirements.
Job Type: Full-time

Pay: ?12,700.81 - ?25,000.00 per month

Benefits:

Provident Fund
Work Location: In person