- Chennai, Tamil Nadu, India
- On-site
- Full-time · Associate
- 0–2 years
Support regulatory data management and compliance with ISO Identification of Medicinal Products (IDMP) standards, manage EMA Article 57 database, ensure data accuracy, and align regulatory submissions with IDMP requirements.
Responsibilities
- Manage and maintain regulatory data within the EMA Article 57 database
- Ensure compliance with IDMP standards and evolving regulatory requirements
- Support the electronic submission of regulatory data to EMA
- Collaborate with cross-functional teams to ensure data consistency and integrity
- Assist in mapping and transformation of medicinal product data to meet IDMP standards
Requirements
- Bachelor’s/Master’s degree in Life Sciences
- Bachelor’s/Master’s degree in Pharmacy
- Bachelor’s/Master’s degree in Regulatory Affairs
- Nice to have: xEVMPD
- Nice to have: pharmaceutical regulatory affairs