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Bristol Myers Squibb (BMS) is hiring a Submission Specialist in Hyderabad, offering a transformative opportunity to work on global clinical trial applications. If you have 1–2 years of pharma experience and aspire to grow in regulatory submissions, CTA documentation, and CTIS workflows, this is a strong career-building role.
This position is ideal for candidates seeking regulatory operations, clinical trial submissions, and CTA dossier management experience with one of the world’s leading biopharmaceutical companies.
Key Responsibilities
As a Submission Specialist, you will:
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- Manage signing and coordination of clinical trial documents (e.g., Power of Attorney).
- Support Senior Specialists/Managers in CTA preparation, including initial filings, protocol amendments & CSR distribution.
- Prepare and distribute global Clinical Trial Application dossiers & substantial amendments.
- Enter and update CTIS data for global CTA dossiers.
- Ensure accuracy and consistency across studies, countries & submission packages.
- Participate in study CTA tracking meetings to maintain timelines and dossier quality.
- Liaise with global teams (Clinical Operations, Safety, Medical, Quality, Protocol Management).
- Ensure compliance with BMS SOPs, global regulations & submission guidelines.
- Use systems such as Veeva & CTMS for tracking and reporting CTA content.
- Contribute to Global Country Requirements Repository.
- Support EU CTR implementation, innovation initiatives & process simplification.
Qualifications & Experience
Educational Requirements
- Bachelor’s / Master’s degree (Science or Technology preferred)
Experience Needed
- 1–2 years of pharmaceutical or clinical research/operations experience
Key Skills
- Understanding of regulatory submissions for non-US clinical trial applications
- Familiarity with CTA documentation, CTIS, CTMS, Excel Trackers
- Strong coordination, communication & documentation skills
- Ability to work with supervision and cross-functional teams
Why Join Bristol Myers Squibb?
- Work on global-scale clinical research documentation
- Opportunities for career growth, learning & cross-functional exposure
- Competitive benefits, flexible working environment & global culture
- Work aligned with the mission: Transforming patients’ lives through science™
Job Location
📍 Hyderabad, Telangana – India
Work Model: On-site / Site-by-design (Hybrid eligibility varies by role)
How to Apply
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