Job Title
Senior Manager, Submission Management – Clinical Trials
Company
Bristol Myers Squibb
Location
Hyderabad, Telangana, India
Employment Type
Full-time
Requisition ID
R1599218
Position Summary
The Senior Manager, Submission Management – Clinical Trials is responsible for leading end-to-end regulatory submission activities for global clinical trials. The role ensures timely, compliant preparation and delivery of clinical trial application (CTA) dossiers and related regulatory documents to global health authorities.
The position also supports continuous improvement initiatives to streamline regulatory processes and enhance operational efficiency across clinical development programs.
Key Responsibilities
Regulatory Strategy and Submission Management
Collaborate with global and local stakeholders to define clinical trial submission strategies and documentation requirements.
Ensure submission deliverables comply with applicable regulatory standards and project timelines.
Prepare, compile, and distribute global Clinical Trial Application (CTA) dossiers.
Manage regulatory documentation for EU CTIS submissions and substantial modifications.
Track regulatory queries, commitments, and ongoing submissions with health authorities.
Coordinate with subject matter experts to develop responses to regulatory questions and information requests.
Monitor regulatory review processes and support negotiations with stakeholders to resolve issues.
Communicate regulatory updates and ensure ongoing compliance across projects.
Provide regular status reporting on submission progress and regulatory commitments.
Continuous Improvement and Process Optimization
Lead initiatives aimed at improving efficiency, simplifying workflows, and enhancing submission processes.
Maintain and update regulatory submission requirements and ensure alignment with current regulations.
Ensure consistency of clinical trial application documentation across studies, countries, and projects.
Promote best practices in regulatory submissions and support process standardization.
Communicate regulatory changes effectively to internal stakeholders.
Team Leadership and Management
Lead and manage a team of direct reports, including workload allocation and project assignment.
Provide coaching, mentoring, and training to team members.
Support team development, performance improvement, and capability building.
Foster innovation and continuous improvement within the team.
Qualifications
Education
Bachelor’s degree (BA/BS), preferably in a science or technology-related field.
Experience
Minimum 7+ years of experience in regulatory submissions within clinical trials or pharmaceutical development.
Strong experience in global clinical trial application processes and health authority interactions.
Skills and Competencies
Regulatory and Technical Expertise
Deep understanding of clinical trial regulatory frameworks and submission processes.
Experience with global regulatory submissions and compliance requirements.
Ability to manage complex regulatory documentation across multiple regions.
Project and Process Management
Strong ability to manage timelines, priorities, and multiple submission activities.
Experience in driving process improvements and operational efficiency.
Leadership and Collaboration
Proven ability to lead and manage teams.
Strong stakeholder management across global, cross-functional teams.
Ability to influence without authority in matrix environments.
Communication Skills
Strong written and verbal communication skills.
Ability to communicate regulatory concepts clearly to technical and non-technical stakeholders.
Additional Information
Focus: Global clinical trial regulatory submissions
Key stakeholders: Regulatory Affairs, Clinical Operations, Global Study Teams, Health Authorities
Working model: Site-based or hybrid depending on role classification
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
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Kyiv |Lima Region :
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Niš |Bohemia :
Prague |Chile :
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