Role & responsibilities

We are looking for an experienced Regulatory Affairs professional who will be responsible for end-to-end regulatory submissions and dossier management for ROW (Rest of World) / Emerging Markets. The candidate should have strong hands-on experience in CTD/eCTD Modules 15 and proven experience in team handling and mentoring.

- Candidate will be responsible for preparing and finalizing CTD/eCTD dossiers for ROW/Emerging Markets.
- Candidate will be responsible for coordinating with R&D; for new product registrations.
- Candidate will be responsible for providing regulatory support and developing regulatory strategies for new products.
- Candidate will be responsible for managing variations, renewals, and regulatory queries.
- Candidate will be responsible for coordinating with QA, QC, Packaging, and Production for regulatory compliance.
- Candidate will be responsible for managing DMF/ASMF, BE/BA data, SOPs, and vendor-related activities.
- Candidate will be responsible for liaising with consultants and Health Authorities for approvals.




- Candidate will be responsible for conducting regulatory risk assessments for site/vendor changes.
- Candidate will be responsible for managing trademark filing and related activities.
- Candidate will be responsible for leading and mentoring the Regulatory Affairs team.
- Candidate will be responsible for providing technical and problem-solving support for regulatory queries.

Preferred candidate profile

- Candidate should be a B.Pharm / M.Pharm graduate with 810 years of relevant Regulatory Affairs experience.
- Candidate should have strong hands-on experience in ROW / Emerging Markets regulatory submissions.
- Candidate should have strong knowledge of CTD/eCTD Modules 1–5 and dossier management.
- Candidate should have experience in handling and mentoring a team of minimum 5 Executives.
- Candidate should have solid knowledge of post-approval variations, renewals, and regulatory queries.
- Candidate should have strong coordination and stakeholder management skills.
- Candidate should have fluent communication skills and good problem-solving abilities.

📌 Regulatory Affairs - Manager - Phama Co - Mumbai
🏢 HRD House
📍 Mumbai