Entry Level Regulatory Affairs Opening at Advanz Pharma

ADVANZ PHARMA, a global leader in specialty, hospital, and rare disease medicines, is hiring a Specialist – Regulatory Operations & Compliance (IDMP & xEVMPD) in Mumbai (Hybrid).

If you are a regulatory affairs professional with expertise in IDMP, xEVMPD submissions, EMA gateway processes, and compliance systems like Veeva Vault RIM, this is an excellent opportunity to contribute to advancing patient care while growing your career.

📝 Key Responsibilities

As a Specialist in Regulatory Operations & Compliance, you will:

• Lead and manage XEVMPD/IDMP submissions, ensuring compliance with EMA and global standards.
• Provide expertise on ISO IDMP Standards, EU Implementation Guide, SPOR, ePI, PLM, PMS, and IRIS implementation.
• Drive IDMP operational strategies including data migration, mapping, cleaning, and enrichment.
• Oversee electronic document management systems and publishing tools.
• Support regulatory systems validation, SOP/WI development, and compliance audits.
• Mentor and train regulatory team members in IDMP/xEVMPD processes.
• Contribute to regulatory intelligence and ensure readiness for evolving global compliance requirements.
• Support M&A projects with data migration and compliance integration.

🎓 Qualifications & Skills

• Graduate/Post-graduate in Life Sciences / Pharmacy / Regulatory Affairs.
• Formal training in Regulatory Affairs.
• Proven experience in XEVMPD submissions, EMA gateway, and IDMP systems.
• Hands-on knowledge of Veeva Vault RIM or similar document management systems.
• Strong grasp of ICH and global regulatory guidelines.
• Excellent project management, communication, and influencing skills.
• Collaborative team player with a solution-oriented, can-do attitude.

💼 Why Join ADVANZ PHARMA?

• Be part of a global healthcare leader specializing in rare and hospital medicines.
• Competitive salary and benefits package.
• Hybrid work model (Mumbai-based with flexibility).
• Inclusive culture with active support for women in leadership (40% of managers are women).
• Career growth opportunities – 25% of employees promoted last year.
• Recognition programs including annual Impact Awards.

📌 Application Process

Application Link