Senior Specialist – CMC Submission Management
Location: Hyderabad, Telangana, India
Job Type: Full-Time
Experience Required: 5+ years in Regulatory Submissions / CMC Submission Management
About the Role
Bristol Myers Squibb (BMS) is seeking an experienced Senior Specialist – CMC Submission Management to manage the preparation, review, and publishing of regulatory submissions for clinical and marketed pharmaceutical products. This role is critical to ensuring timely, accurate, and compliant submission of documents to global Health Authorities, supporting BMS’s mission of transforming patients’ lives through science.
The ideal candidate will have hands-on experience in CMC submission processes, regulatory publishing tools, and cross-functional collaboration with project teams, quality, and regulatory stakeholders.
Key Responsibilities
Track, collect, review, and compile all components for submissions to Health Authorities.
Prepare submission documents including Cover Letters, FDA Forms, and content plans for Investigational and Marketed Applications (CSR, Variations, DSURs, PSURs, Initial IND Submission).
Coordinate IND, NDA, BLA, Orphan Drug, and Annual Report submissions.
Build and manage CARA/PRISM structures for global CMC submissions.
Perform submission publishing activities using tools like DocuBridge, Lorenz, Veeva, or equivalent software.
Ensure compliance with global regulatory frameworks and submission guidelines.
Facilitate submission team meetings and participate in kick-off meetings, representing RISM and driving publishing timelines.
Develop and update departmental process documents, SOPs, and job aids.
Support non-eCTD submissions in coordination with the International Regulatory Team.
Proactively identify issues, propose solutions, and escalate as needed to ensure deadlines are met.
Qualifications & Experience
Education: BA/BS degree in Science, Technology, or related field preferred.
Experience: Minimum 5 years of relevant experience in regulatory submissions, CMC submission management, or regulatory publishing.
Technical Skills:
Foundational knowledge of global regulatory practices and submission requirements.
Proficiency with Microsoft Office Suite, Adobe Acrobat, SharePoint.
Hands-on experience with submission publishing tools (DocuBridge, Lorenz, Veeva).
Professional Skills:
Strong attention to detail and ability to manage multiple priorities.
Effective written and oral communication skills in English.
Basic presentation skills to communicate effectively with internal and external stakeholders.
Critical thinking and problem-solving abilities aligned with regulatory objectives.
Ability to work independently while engaging with cross-functional teams globally.
Why Join BMS?
Work on meaningful, impactful projects that advance patient health and global healthcare innovation.
Join a culture that values curiosity, innovation, accountability, and inclusion.
Gain opportunities to collaborate with high-achieving teams and develop professionally on a global scale.
Flexible work models including site-essential and hybrid roles depending on business requirements.
Access to comprehensive employee resources, development programs, and support for career growth.
At BMS, every employee contributes to a vision of “Transforming patients’ lives through science™”. We empower our teams to innovate, learn, and excel in a supportive, inclusive environment.
Apply Now to be part of a global team driving CMC submission excellence and ensuring regulatory compliance that impacts millions of patients worldwide.
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Siliguri |Illinois :
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Kyiv |Lima Region :
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