Job Title: Senior Executive, Regulatory Operations and Compliance
Location: Andheri, Mumbai (Hybrid working)
About the Role
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Senior Executive, Regulatory Operations & Compliance to join our Regulatory Publishing team.
The primary purpose of this role is to support ADVANZ PHARMA’s Regulatory function through the execution and coordination of XEVMPD/IDMP submissions, ensuring all submissions meet applicable internal quality standards and external regulatory requirements. The role will contribute to XEVMPD/IDMP implementation activities and support the development of processes that enhance regulatory data management and compliance.
The position is responsible for supporting the maintenance of XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) and IDMP data, with a solid focus on ensuring ongoing compliance with European Article 57 requirements and related regulatory obligations.
The role will also support the implementation,
maintenance, and continuous improvement of Regulatory systems and processes, working collaboratively with cross-functional stakeholders to help ADVANZ PHARMA meet its regional and global regulatory commitments
What You'll Be Responsible For
Execute and coordinate XEVMPD/IDMP submissions, ensuring electronic submissions meet internal quality standards and external regulatory requirements within agreed timelines.
Provide operational support and subject matter knowledge related to ISO IDMP standards, EU Implementation Guide, SPOR, ePI, PLM, PMS and IRIS requirements.
Support the execution of IDMP operational activities and contribute to ongoing IDMP implementation initiatives.
Contribute to the development, implementation and continuous improvement of regulatory processes, procedures and system-related workflows.
Collaborate with cross-functional stakeholders to support the implementation, mai