Bristol Myers Squibb (BMS), a global leader in pharmaceuticals and clinical research, is hiring for the role of Submission Specialist in Hyderabad. This opportunity offers meaningful work supporting global clinical trial submissions and regulatory documentation, advancing lifesaving therapies.
If you’re looking for a regulatory affairs job, clinical submissions role, or breakthrough career in the pharmaceutical industry, this is a great opportunity—especially for professionals with 1–2 years of industry experience.
Role Overview
As a Submission Specialist, you will support clinical trial applications (CTA), document coordination, regulatory submissions, and compliance with EU CTIS and global health authority requirements.
The role demands strong organizational skills, attention to detail, and collaboration with cross-functional teams across regulatory, quality, safety, medical writing, and operations.
Key Responsibilities
- Manage signing and execution of clinical trial documentation including Power of Attorney and regulatory letters.
- Support CTA preparation, amendments, renewals, and trial closeout submissions.
- Ensure accuracy, compliance, and consistency across clinical submission packages.
- Prepare data and records in CTIS for EU and global submissions.
- Coordinate clinical trial application dossiers for CROs and country teams.
- Track submissions using tools like Veeva Vault and CTMS.
- Participate in global study tracking meetings and escalate delays or submission risks.
- Contribute to global regulatory requirement repositories.
- Support automation, innovation, and continuous improvement initiatives.
Required Qualifications
✔ BA/BSc in Life Sciences, Pharmacy, Biotechnology, or related field
✔ 1–2 years of experience in pharmaceutical, clinical research, or regulatory submissions
✔ Knowledge of clinical trial submission process and documentation
✔ Ability to work in cross-functional global teams and handle multiple priorities
Preferred Skills
- Experience with Veeva Vault
- Understanding of EU CTR and CTIS
- Clinical Research background (CRA, CTA, TMF, Regulatory)
- Strong communication and document handling skills
Benefits & Culture
BMS offers:
✨ Competitive compensation & insurance
✨ Work-life balance and hybrid work structure (role-based)
✨ Growth programs, certifications & global exposure
✨ Inclusive culture and employee support programs
How to Apply
