AP
Hiring companyAdvanz Pharma
Verified today
Senior Executive, Regulatory Operations & Compliance
Andheri, Mumbai, India Full-time Hybrid
About the role
Regulatory Publishing team at Advanz Pharma ensures accurate and compliant regulatory data submissions. The Senior Executive drives XEVMPD/IDMP submission execution, supports system implementation, and improves data management processes. Based in Andheri, Mumbai with a hybrid work model, the role collaborates across functions to maintain regulatory compliance and support global commitments.
What you’ll do
- Execute and coordinate XEVMPD/IDMP submissions meeting quality and regulatory standards
- Provide operational support for ISO IDMP standards, EU Implementation Guide, SPOR, ePI, PLM, PMS and IRIS
- Develop and improve regulatory processes, procedures and system workflows
- Collaborate with cross‑functional stakeholders on RIMS, EDMS, publishing systems and platform maintenance
- Monitor regulatory requirement changes and ensure compliance
- Create, quality‑check and support compliance activities for submissions and data
- Perform IDMP data migration, mapping, cleansing and validation
- Support system testing, validation and implementation projects
What you’ll bring
- Degree or Post‑graduation in Pharmacy
- 5+ years experience with XEVMPD submissions to EMA
- Hands‑on experience with Veeva Vault RIM or similar EDMS
- Strong knowledge of ICH and regional regulatory guidelines
- Experience implementing regulatory systems for XEVMPD/ISO IDMP
Skills
Regulatory submissionsIDMP complianceEDMS managementData migrationProcess improvementCross‑functional collaborationSystem testingStakeholder communication
Benefits
- Global recognition programme
- Employee assistance programme
- Wellbeing day and birthday leave
- Volunteering and compassionate leave
- Agile working and work‑from‑anywhere options
Education
Pharmacy degree