Executive – Regulatory Affairs
Sun Pharma
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Job Description
Location: Hyderabad, Telangana, India
Job Type: Full-Time | Work Model: Site-by-Design (Hybrid eligibility)
Company: Bristol Myers Squibb
Introduction
At Bristol Myers Squibb (BMS), work is more than a job — it’s about transforming lives. With our mission of “Transforming patients’ lives through science™”, every role is uniquely meaningful, from pioneering cell therapy breakthroughs to advancing global clinical trials. As an eTMF Operations Analyst, you will help ensure the accuracy, compliance, and quality of clinical trial documentation that drives life-changing therapies forward.
Role & Responsibilities
- Apply deep knowledge of ALCOA+ standards, Good Clinical Practice (GCP), Good Documentation Practices (GDP), and ICH E6(R2) guidelines.
- Perform critical reviews of clinical trial documentation, applying disciplined analytical and decision-making processes.
- Manage and maintain clinical content in electronic Trial Master File (eTMF) systems, preferably Veeva Vault eTMF.
- Ensure quality, compliance, and timely documentation management throughout the clinical trial lifecycle.
- Communicate effectively with global stakeholders through strong written and verbal skills.
Independently manage projects, handle concurrent tasks, and deliver results in a fast-paced environment.
Educational Qualification
Education:
- Bachelor’s degree in a scientific or related discipline (minimum requirement).
Experience:
- 3–5 years of eTMF and clinical trial experience.
- Prior experience using Veeva Vault eTMF (preferred).
- Proven ability to independently manage projects with multiple priorities.
Skills & Competencies:
- Strong understanding of regulatory and compliance frameworks.
- Critical thinking and analytical decision-making.
- Excellent organizational and communication skills.
- Ability to work in dynamic, cross-functional teams.
Location
Hyderabad, Telangana, India
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