Submission Specialist | Hyderabad, Telangana, India
Experience Required: 0–2 years
Education: BA/BS in Science, Technology, or related field preferred
Job Category: Regulatory Affairs | Employment Type: Full-Time
Company Overview
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to transforming patients’ lives through science. With innovative research in oncology, immunology, cardiovascular, and rare diseases, BMS delivers life-changing therapies worldwide. Employees at BMS work in an inspiring, collaborative environment where professional growth, scientific innovation, and meaningful impact are at the core of every role.
Role Overview
The Submission Specialist will manage regulatory submission activities for routine submissions to Health Authorities, ensuring compliance with global standards. This entry-level role is ideal for candidates seeking hands-on experience in regulatory operations, submission verification, and interaction with internal and external stakeholders within a pharmaceutical or biotech environment.
Key Responsibilities
Track, collect, and review submission components to Health Authorities.
Interact with responsible parties to ensure quality and completeness of submission documents.
Troubleshoot issues in submission components and coordinate clarifications or revisions.
Prepare Cover Letters, FDA Forms, and submission content plans for routine submissions.
Verify submissions for eCTD compliance and update Regulatory Information Management (RIM) systems.
Participate in submission team meetings and coordinate non-eCTD submissions with international regulatory teams.
Perform miscellaneous regulatory operations activities as required.
Candidate Profile
Experience & Skills:
0–2 years of experience in pharmaceutical regulatory operations or related roles.
Foundational knowledge of global regulatory practices, submission guidelines, and Health Authority requirements.
Ability to resolve issues promptly and escalate as appropriate.
Strong written and verbal communication skills in English; effective in cross-functional collaboration.
Basic presentation skills for delivering content to diverse audiences.
Attention to detail and ability to prioritize tasks within a project.
Proficient in desktop applications (MS Office) and comfortable with R&D software tools.
Education:
BA/BS in Science, Technology, or related discipline preferred.
Work Environment:
On-site or hybrid as per site-essential, site-by-design, or remote-by-design role requirements.
Commitment to collaboration, innovation, and compliance with company policies and occupational safety standards.
Why Join BMS?
Contribute to projects that directly impact patients’ lives.
Gain experience in regulatory submission management and global Health Authority compliance.
Work alongside high-performing teams with opportunities for professional growth.
Participate in a culture guided by passion, innovation, accountability, inclusion, and integrity.
Benefit from competitive compensation, training programs, and a supportive work environment.
Gujarat :
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