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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Frank Scottile Blvd |Missouri :
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Rostock |Saarland :
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Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Wavre |Tipperary :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Montreal |Brussels :
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Zaventem |South America :
Argentina | Peru |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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