Senior Manager, Submission Management – Clinical Trials
Location: Hyderabad, Telangana, India
Job ID: R1599218
Company: Bristol Myers Squibb
Role Summary
The Senior Manager, Submission Management – Clinical Trials is responsible for leading end-to-end regulatory submission activities for global clinical development programs. This role oversees the preparation, compilation, tracking, and maintenance of clinical trial applications (CTAs) and regulatory submissions, ensuring compliance with global regulatory requirements and project timelines. The position also provides leadership, process improvement, and team management support within the regulatory operations function.
Key Responsibilities
Regulatory Submission Management
Lead end-to-end clinical trial submission activities for assigned global development projects.
Collaborate with global and local regulatory stakeholders to define submission strategies and timelines.
Coordinate preparation, compilation, review, and submission of Clinical Trial Applications (CTAs) and related regulatory documents.
Ensure submission packages meet global regulatory requirements and company standards.
Prepare and distribute global CTA dossiers for health authority submissions.
Manage regulatory data and documentation required for EU Clinical Trials Information System (CTIS) submissions and substantial modifications.
Regulatory Compliance & Health Authority Interactions
Assess submission deliverables to ensure regulatory compliance and quality.
Monitor regulatory review and assessment activities.
Coordinate responses to health authority questions, requests, and commitments.
Collaborate with subject matter experts to develop accurate regulatory responses.
Track regulatory commitments, queries, approvals, and submission milestones.
Communicate evolving regulatory requirements and changes to internal stakeholders.
Project & Stakeholder Management
Partner with cross-functional teams including Regulatory Affairs, Clinical Operations, Medical Writing, Data Management, and Quality functions.
Drive alignment between submission strategies and project timelines.
Negotiate priorities and resolve submission-related challenges with stakeholders.
Provide regular status updates on submission activities and regulatory commitments.
Support global regulatory planning and execution activities.
Continuous Improvement & Process Excellence
Lead initiatives focused on process simplification, innovation, and operational efficiency.
Support the maintenance of global regulatory intelligence and submission requirements.
Ensure consistency and standardization of clinical trial applications across studies and countries.
Contribute to the development and implementation of best practices within submission management.
Identify opportunities for automation and process optimization.
Team Leadership & People Management
Lead and mentor a team of regulatory submission professionals.
Manage resource allocation and workload planning across projects.
Provide coaching, training, and professional development opportunities for team members.
Foster a culture of collaboration, innovation, and continuous improvement.
Support talent development and succession planning initiatives.
Required Qualifications
Education
Bachelor's Degree (BA/BS) in:
Life Sciences
Pharmacy
Biotechnology
Biological Sciences
Health Sciences
Regulatory Affairs
Science or Technology-related discipline
Experience
10+ years of experience in Regulatory Affairs, Regulatory Operations, or Regulatory Submission Management.
Extensive experience managing global clinical trial submissions.
Experience supporting Clinical Trial Applications (CTAs) and regulatory submissions across multiple regions.
Experience interacting with global health authorities and regulatory agencies.
Prior experience leading teams and managing complex regulatory projects.
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 :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | 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) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Concord | Lumberton | North Carolina |Michigan :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Lisbon | Oeiras | Portugal |WI :
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Rostock |Saarland :
Saarbrucken |Switzerland :
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 :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Australia | Renfrew | North York | Richmond Hill | Mississauga | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
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Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Seoul |Kazakhstan :
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Green Way | Medan | Minnesota | Remote - Middle East | Victoria | Hungary | Riga | Lenexa | Melbourne | Hammond | Blue Bell | Manipal | Perth | Ireland | Remote - Africa | Castlebar | Slovakia | Lousiana | Bishop | Bountiful | Xzagreb | Belgium | Leinster | Faridabad | Springville | Switzerland | Nairobi | Remote - Europe | Tulsa | Remote - South America (Latin Americal) | Zaragoza | McFarland | Thailand | Milwaukee | Texas | Regulatory Labeling Manager (NA and LATAM Only) | French |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
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Najran | Riyadh | King Abdullah Economic City | Rabigh | Khulais | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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