Clinical Project Assistant
SanofiÂ
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Job Description
Date Posted: June 14, 2025
Location: Navi Mumbai, India (400706)
Company: Teva Pharmaceuticals
Job ID: 61916
Job Type: Full-time
Introduction
The Regulatory Affairs Associate I will support the Global Regulatory Operations (GRO) Regulatory Data Analytics team by managing regulatory product registration data in compliance with xEVMPD (Article 57) requirements and internal global standards.
This role focuses on ensuring data accuracy, integrity, and compliance across Teva’s global registration databases. You will be an integral part of a team that enables regulatory excellence, supports data-driven decisions, and ensures Teva’s continued compliance with international regulatory expectations.
Role & Responsibilities
- Execute Regulatory Data Analytics operations in accordance with Work Instructions (WIs) and Standard Operating Procedures (SOPs).
- Manage product registration data, sourcing accurate information from regulatory dossiers and documentation.
- Maintain a detailed understanding of regulatory dossier structures, registration data frameworks, and system workflows.
- Perform data integrity and quality control (QC) checks to ensure accuracy and completeness of Teva’s global registration databases.
- Support Article 57/xEVMPD compliance by managing regulatory product data and system records.
- Collaborate with Global Regulatory Affairs (GRA) teams to ensure consistent, high-quality data standards.
- Contribute to projects that enhance regulatory data quality, data reuse, and system integration across regulatory platforms.
- Participate in business or technology initiatives impacting regulatory data and digital systems.
- Represent GRO Regulatory Data Analytics within cross-functional GRA meetings and working groups.
- Foster effective communication and relationships with global stakeholders and internal customers.
Educational Qualification
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- Bachelor’s or Master’s degree in Life Sciences or Information Technology.
- Master’s degree in a scientific or IT discipline.
Experience & Skills
- 1–3 years of relevant experience (preferably in Regulatory Operations or Regulatory Affairs).
- Strong interest in pharmaceutical regulatory affairs and regulatory data management.
- Understanding of regulatory information systems and data integrity principles.
Location
Navi Mumbai, India (400706)
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