Confidential Pharma Hiring (HO) Regulatory Affairs Officer
- Officer – Regulatory Affairs Opportunity in Mumbai (B. Pharma/M. Pharma)
- Why You Should Apply
- Key Responsibilities
- H2: Dossier Preparation & Regulatory Submission
- H3: Regulatory Communication & Documentation Review
- H3: Cross-Departmental Coordination
- H4: Compliance & Documentation Management
- Required Qualifications and Skills
- Application Details
- Pharma Job Summary Table
New Job Opening for Regulatory Affairs Professionals – B. Pharma/M. Pharma – Fort CSMT, Mumbai
Explore a career in Regulatory Affairs at a reputed pharma company in Fort, CSMT Mumbai. Hiring B. Pharma/M. Pharma with 1–2 years experience in ACTD/CTD/ECTD Dossier preparation.
Officer – Regulatory Affairs Opportunity in Mumbai (B. Pharma/M. Pharma)
Join one of the top pharmaceutical firms in Mumbai and become a part of an innovative and compliance-driven team. We’re hiring Regulatory Affairs Officers with 1–2 years of experience in ACTD/CTD/ECTD Dossier preparation for the ROW market. This is a full-time, 5-day work week role based out of our Head Office near Fort – CSMT, Mumbai.
Why You Should Apply
- Work in a central Mumbai location with a reputed pharma employer
- Gain international exposure by preparing dossiers for the Rest of World (ROW) market
- Enjoy a professional work environment with weekends off (Saturday-Sunday)
Key Responsibilities
H2: Dossier Preparation & Regulatory Submission
- Prepare ACTD/CTD/eCTD dossiers for country-specific registrations in ROW markets
- Ensure timely and error-free submissions aligned with the marketing team’s deadlines
H3: Regulatory Communication & Documentation Review
- Respond to health authority queries and ensure timely, compliant responses
- Review technical documentation (Process Validation, AMV, Stability, CDP) from QA, R&D/ADL
H3: Cross-Departmental Coordination
- Liaise with internal teams (HO/Plant/ADL/R&D) for sample procurement and documentation
- Verify artworks and support commercial registrations as per local regulatory needs
H4: Compliance & Documentation Management
- Maintain proper records of dossiers, submissions, approvals, and artwork status
Required Qualifications and Skills
- Education: B. Pharma / M. Pharma
- Experience: 1–2 years of relevant Regulatory Affairs experience
- Technical Requirement: Must have hands-on experience in Dossier Preparation (ACTD/CTD/eCTD) for ROW markets
Application Details
Location: Fort – CSMT, Mumbai
Working Days: Monday to Friday (5-Day Week)
Apply Now: Share your updated CV with the HR team at the earliest
Pharma Job Summary Table
| Company Name | Current Vacancies | Required Education | Experience Required |
|---|---|---|---|
| Confidential Pharma (HO) | Regulatory Affairs Officer | B. Pharma / M. Pharma | 1–2 Years |
To apply for this job please visit encoregroup.net.
