BPharm/MPharm Specialist Job – at Bristol Myers Squibb, Apply Now!
Join Bristol Myers Squibb as a Specialist in Submission Management and contribute to life-changing work in global regulatory affairs. This Hyderabad-based role is ideal for experienced professionals (3+ years) in regulatory operations with hands-on experience in submission planning, publishing, and Health Authority documentation. Be part of a mission-driven team that’s transforming patients’ lives through science.
- Job Title: Specialist – Submission Management
- Location: Hyderabad, Telangana
About the Company:
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career further than you thought possible.
Description for BPharm/MPharm Specialist Job :
At Bristol Myers Squibb, your work has purpose—transforming patients’ lives through science. We are hiring a Submission Management Specialist for our Hyderabad site. In this role, you’ll support routine regulatory submissions, ensure document compliance, and contribute to high-quality global regulatory operations.
You’ll join a collaborative team dedicated to innovation, quality, and compliance in drug development. This is your opportunity to grow within a global biopharma leader known for breakthrough science and a people-first culture.
Key Responsibilities for BPharm/MPharm Specialist Job:
- Track, collect, and review components for routine Health Authority submissions.
- Coordinate with cross-functional teams to ensure high-quality submission documents.
- Prepare FDA forms, cover letters, and content plans for submissions.
- Troubleshoot submission issues and ensure eCTD compliance.
- Update RIM systems with planned and submitted regulatory data.
- Participate in submission team meetings and collaborate with international regulatory teams.
- Manage non-ECTD submissions as needed.
- Ensure timely escalation and resolution of submission issues.
Required Qualifications for BPharm/MPharm Specialist Job:
- Bachelor’s or Master’s in Pharmacy (B.Pharm/M.Pharm).
- Minimum 3 years of experience in regulatory submissions and document handling.
- Familiarity with eCTD publishing and global regulatory submission formats.
- Strong communication skills (written and verbal).
- Proficiency in desktop software and document management systems.
- Strong attention to detail and ability to manage multiple priorities.
Keywords: Bristol Myers Squibb, Specialist, Submission Management, Regulatory Submissions, Health Authorities, Clinical Trials, Pharmaceutical, B-Pharm, M-Pharm, Covid-19 Vaccination, Equal Employment Opportunity, Workplace Accommodations
