Submission Specialist – Regulatory Operations
Job ID: R1597213
Company: Bristol Myers Squibb (BMS)
Location: Hyderabad, Telangana, India
Employment Type: Full-time
Work Model: Site-based / Site-by-design (as per role requirements)
Industry: Pharmaceuticals | Regulatory Affairs | Regulatory Operations
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company driven by a singular vision: Transforming patients’ lives through science. At BMS, employees work on meaningful, high-impact projects that advance innovative therapies across R&D, regulatory, and manufacturing functions. The organization fosters a culture of integrity, inclusion, collaboration, and scientific excellence, offering career opportunities that are both challenging and rewarding.
Job Overview
Bristol Myers Squibb is seeking a detail-oriented Submission Specialist to support regulatory submission activities by ensuring the accurate, timely, and compliant preparation of submission packages for global health authorities. This early-career role is ideal for professionals with foundational knowledge of regulatory submissions, eCTD compliance, and regulatory information management systems (RIM).
The role supports routine submissions and works closely with cross-functional stakeholders to maintain high-quality regulatory deliverables.
Key Responsibilities
Regulatory Submissions & Documentation
Track, collect, review, and manage components required for routine submissions to global Health Authorities
Prepare cover letters, FDA forms, and submission content plans for routine regulatory submissions
Perform submission verification to confirm eCTD compliance prior to and post-publishing
Coordinate non-eCTD submissions in collaboration with International Regulatory Team Leads
Stakeholder Collaboration & Issue Resolution
Interact with responsible functional teams to ensure submission components meet quality and regulatory standards
Identify, troubleshoot, and resolve issues in submission components by coordinating revisions and clarifications
Participate in submission team meetings and provide timely updates on submission status
Regulatory Systems & Operational Support
Update and maintain Regulatory Information Management (RIM) systems with planned and submitted U.S. regulatory activities
Support additional regulatory operations activities as required to meet business objectives
Educational Qualifications
Bachelor’s degree (BA/BS) in Science, Technology, Life Sciences, or a related discipline
Experience Required
0 to 2 years of experience in the pharmaceutical, biotechnology, or regulatory environment
Exposure to regulatory submissions, regulatory operations, or R&D support roles is preferred
Key Skills & Competencies
Foundational understanding of global regulatory practices, submission guidelines, and requirements
Strong attention to detail with the ability to prioritize tasks effectively
Proficiency in English (written and verbal) with the ability to communicate clearly across global teams
Basic project coordination and presentation skills
Ability to identify issues, escalate appropriately, and engage relevant stakeholders for resolution
Critical thinking and problem-solving skills aligned with organizational objectives
Proficiency with desktop application software (MS Office or equivalent)
Practical knowledge of computer systems used in R&D or regulatory environments
Work Environment & On-Site Expectations
BMS follows an occupancy-based work model depending on the nature of the role:
Site-essential: 100% on-site presence required
Site-by-design: Hybrid model with a minimum of 50% on-site presence
Field-based / Remote-by-design: Travel-based or remote roles as applicable
On-site presence is considered essential for collaboration, innovation, and productivity.
Inclusion, Accessibility & Equal Opportunity
Bristol Myers Squibb is committed to fostering a diverse and inclusive workplace. Qualified applicants are considered without regard to age, race, color, religion, gender, sexual orientation, gender identity or expression, disability, veteran status, or any other legally protected characteristic.
Reasonable workplace accommodations are available for candidates with disabilities throughout the recruitment process.
Data Protection & Candidate Rights
BMS does not request payments or sensitive financial information during the recruitment process. All applicant data is processed in accordance with applicable data protection and privacy regulations.
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