? Hiring: Assistant Manager – Regulatory Affairs

? Location: Pune, Maharashtra

? Experience: 5–10 Years

? Qualification: M.Pharm

? Industry: Pharmaceutical

Salary : 15LPA

We are hiring an experienced Assistant Manager – Regulatory Affairs for a leading pharmaceutical organization in Pune.

The ideal candidate will have solid experience in International Regulatory Affairs , particularly in CTD dossier preparation/evaluation, EU regulatory procedures, and international submissions .

Key Responsibilities:

- Manage and coordinate international regulatory submissions to Ministries of Health (MoH) and other regulatory authorities

• Prepare, review and evaluate CTD/eCTD dossiers • Handle EU DCP, MRP and National Procedures

- Prepare and coordinate responses to regulatory queries and deficiencies

• Ensure compliance with ICH guidelines and EU/EMA regulations

• Manage regulatory activities for Morocco and/or Francophone African markets





- Coordinate with cross-functional teams for dossier preparation and submissions
- Track submissions, approvals and regulatory commitments

Required Skills:

✅ M.Pharm qualification

✅ 5–10 years of experience in Regulatory Affairs

✅ Strong experience in CTD/eCTD dossier preparation and evaluation

✅ Hands-on experience with EU DCP / MRP / National Procedures

✅ Experience in international pharmaceutical regulatory submissions

✅ Good knowledge of ICH guidelines and EU/EMA regulations

✅ Experience with Morocco and/or Francophone African regulatory agencies is highly preferred

✅ French language proficiency is preferred

✅ Strong communication and coordination skills

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📌 Assistant Manager – Regulatory Affairs (Pune)
🏢 Alliance Recruitment Agency
📍 Pune