Role: Regulatory Submissions Specialist / CMC Submission Specialist
Company: Bristol Myers Squibb (BMS)
Location: [Specify Location or “Global / Multiple Locations”]
Experience Level: 5+ years relevant experience
Employment Type: [Full-time / Hybrid / On-site per role requirement]
About Bristol Myers Squibb
At Bristol Myers Squibb (BMS), work is challenging, meaningful, and life-changing. Each day brings opportunities to contribute to groundbreaking science that transforms patients’ lives — and careers. From optimizing production processes to advancing cell therapy breakthroughs, BMS empowers its people to grow and thrive within a dynamic, inclusive, and innovative environment.
We also recognize the importance of balance and flexibility, offering a range of competitive benefits, services, and programs to support employees both professionally and personally.
Learn more: careers.bms.com/working-with-us
Key Responsibilities
Regulatory Submissions & Documentation
Track, collect, and review all components required for submission to Health Authorities.
Perform submission publishing activities in accordance with regulatory standards.
Prepare key submission documents, including:
Cover Letters
FDA Forms
Submission Content Plans
Investigational and Marketed Application Submissions (CSR, Variations, DSURs, PSURs, Initial INDs)
Coordination & Communication
Attend and facilitate submission team meetings and kick-off discussions.
Represent RISM in submission planning and ensure timely delivery of publishing milestones.
Coordinate:
Initial IND kick-off submissions
IND, NDA, BLA, and Orphan Drug Annual Reports
Collaborate with International Regulatory Teams for non-eCTD submissions.
Process Development & Support
Develop or update job aid documents to support departmental processes.
Build and manage CARA/PRISM structures for Global CMC Submissions.
Participate in focused projects and cross-functional initiatives related to submission management.
Requirements
Experience & Knowledge
Minimum 5 years of relevant regulatory submissions experience.
Strong foundational understanding of global regulatory practices, guidelines, and requirements.
Proven ability to implement short- and long-term goals within a regulatory team setting (RISM).
Proficiency in Microsoft Office Suite, Adobe Acrobat, and SharePoint.
Familiarity with regulatory systems and publishing tools (CARA, PRISM, etc.).
Skills & Competencies
Strong written and verbal communication skills in English.
Effective cross-cultural communication, including with non-English speakers.
Ability to manage multiple tasks with high attention to detail.
Demonstrated problem-solving and critical thinking skills.
Ability to prioritize, manage timelines, and deliver results.
Basic presentation skills to convey content to diverse audiences.
Proactive, solutions-oriented approach to project challenges.
Education
Bachelor’s degree (BA/BS) in a Science or Technology field preferred.
Work Environment: On-site Protocol
BMS assigns work models based on the nature of each role:
Site-Essential: 100% on-site presence required.
Site-by-Design: Hybrid work model (≥50% onsite).
Field-Based / Remote-by-Design: Flexible, with travel for meetings or site visits as required.
On-site presence is considered essential for collaboration, innovation, and productivity.
Inclusion, Accessibility & Equal Opportunity
BMS is committed to diversity, inclusion, and accessibility in every aspect of employment.
Candidates with disabilities may request reasonable accommodations during the recruitment process.
Contact: adastaffingsupport@bms.com
Equal Employment Opportunity Statement: careers.bms.com/eeo-accessibility
Additional Information
BMS strongly recommends that all employees be fully vaccinated for COVID-19 and remain up to date with boosters.
Qualified applicants with arrest or conviction records will be considered in accordance with applicable laws.
For Los Angeles County applicants, visit: careers.bms.com/california-residents
All application data will be handled in compliance with relevant data privacy laws and policies.
Our Vision: Transforming Patients’ Lives Through Science™
At BMS, every employee contributes to our mission of transforming patients’ lives through science. Guided by our shared values — Passion, Innovation, Urgency, Accountability, Inclusion, and Integrity — we create a workplace where every idea and every person can thrive.
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Hubei :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
North York | Renfrew | Uxbridge | Mississauga | Richmond Hill | Australia |Quebec :
Montreal |Chile :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
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North Ostrobothnia :
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Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
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Jakarta |Israel :
Tel Aviv | Kfar Saba | Be'Er Sheva | Netanya | Yavne |Italy :
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Japan | Saitama |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
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Seoul |Kuala Lumpur :
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Ciudad de México |New Zealand :
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Niš |Singapore :
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Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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