Bristol Myers Squibb Hiring for Submissions Specialist and regulatory roles.
Bristol Myers Squibb Recruitment 2025: Specialist – Clinical Trial Submissions
Bristol Myers Squibb (BMS), one of the world’s most respected biopharmaceutical companies, is hiring for the position of Specialist at its Hyderabad, Telangana, India location. This is a full-time role focused on supporting global clinical trial submissions, managing documentation, coordinating with multiple internal teams, and ensuring compliance with regulatory and ethical standards. The position is listed under requisition ID R1596499 and was posted recently. Bristol Myers Squibb Hiring for Submissions Specialist
This job offers a unique opportunity for professionals who aspire to work in the clinical research, regulatory submissions, and trial operations domain. Bristol Myers Squibb is widely known for its culture of innovation, scientific excellence, and commitment to transforming patients’ lives through science. Working at BMS is not just a job; it provides meaningful exposure, career expansion opportunities, and the chance to contribute to breakthrough research and global health solutions. Bristol Myers Squibb Hiring for Submissions Specialist
If you are someone who seeks challenging work, global collaboration, and impactful responsibilities in clinical trial operations, this Specialist role offers the right platform to grow your career. Bristol Myers Squibb Hiring for Submissions Specialist
About Bristol Myers Squibb
BMS is a global biopharmaceutical leader focused on discovering, developing, and delivering innovative medicines. The company emphasizes a supportive work environment, work-life balance, and continuous skill development. Employees are encouraged to take ownership of their growth while working alongside highly talented teams across clinical operations, regulatory affairs, safety, quality, and research.
The company values passion, innovation, inclusion, accountability, urgency, and integrity. Every employee plays a part in fulfilling the company’s vision of Transforming patients’ lives through science™. Bristol Myers Squibb Hiring for Submissions Specialist
Position Overview: Specialist – Clinical Trial Submissions
The Specialist plays a vital role in managing and coordinating Clinical Trial Application (CTA) documentation for global trials. The responsibilities include preparing core submission documents, ensuring timely delivery to Health Authority (HA) and Ethics Committee (EC) applicants, coordinating signatures, and supporting the Clinical Trial Information System (CTIS) requirements under EU regulations. Bristol Myers Squibb Hiring for Submissions Specialist
This role requires strong organization skills, coordination ability, attention to detail, and a good understanding of regulatory submission processes.
Key Responsibilities
The Specialist is expected to manage a broad range of activities related to clinical trial submissions and documentation. A detailed overview is provided below: Bristol Myers Squibb Hiring for Submissions Specialist
1. Coordination of CTA Documentation
One of the primary responsibilities is managing the signing and processing of critical documentation for clinical trials. This includes powers of attorney, approval forms, and other essential trial documents. The role requires:
- Coordinating multiple document signings simultaneously
- Ensuring accuracy, timely circulation, and tracking of documents
- Working closely with stakeholders involved in trial approvals
This function ensures that all required documents are ready and compliant before submission to authorities.
2. Support in CTA Preparation Activities
The Specialist will provide support to Senior Specialists and Managers for CTA preparation, including:
- Initial CTA filings
- Startup activities
- Protocol amendments
- End-of-trial documentation
- CSR (Clinical Study Report) distribution
This requires an understanding of clinical operations, study timelines, and regulatory expectations. Bristol Myers Squibb Hiring for Submissions Specialist
3. Preparation and Distribution of Global CTA Dossiers
Another essential responsibility is preparing CTA dossiers for global submissions and distributing them to:
- Country applicants
- Contract Research Organizations (CROs)
- Ethics Committees (ECs)
- Health Authorities (HAs)
The Specialist must ensure the dossiers are complete, accurate, and formatted according to regional regulations.
4. CTIS Data Preparation (EU Regulation)
Since the EU Clinical Trial Regulation requires submission through the Clinical Trial Information System (CTIS), the Specialist will:
- Prepare required data for CTIS submissions
- Support substantial modifications and follow-up updates
- Ensure alignment with EU regulatory requirements
This responsibility is crucial for trials being conducted in European Union regions. Bristol Myers Squibb Hiring for Submissions Specialist
5. Ensuring Consistency Across Studies and Countries
The Specialist must ensure regulatory documentation remains consistent across:
- Multiple studies
- Different countries
- Entire clinical programs
Consistency in submission content improves compliance and prevents delays in approvals. Bristol Myers Squibb Hiring for Submissions Specialist
6. Participation in CTA Tracking Meetings
The Specialist participates in study-level or program-level CTA tracking meetings led by senior team members. This includes:
- Reviewing timelines
- Monitoring dossier readiness
- Addressing challenges and dependencies
- Coordinating with cross-functional teams
Proactive communication helps maintain submission accuracy and efficiency.
7. Cross-Functional Coordination
To ensure CTAs remain compliant with global timelines and guidelines, the Specialist interacts with:
- Country offices
- Clinical Supply Operations
- Operation Leads
- Protocol Managers
- Medical Monitors
- Safety Teams
- Quality Assurance teams
This cross-functional collaboration ensures seamless CTA preparation and submission.
8. Regulatory Tools and Tracking Systems
The Specialist must comply with planning and tracking tools such as:
- Veeva HA Submission and Approval Tracking System
- Clinical Trial Management Systems (CTMS)
- Spreadsheets and Excel-based trackers
These tools help generate reports, monitor progress, and track submission statuses.
9. Escalation and Issue Resolution
If delays, trends, or risks are identified, the Specialist must:
- Escalate them to study teams
- Inform GSM-CT senior roles
- Support timely resolution
This helps maintain adherence to study timelines and reduces regulatory submission risks.
10. Contribution to Global Country Requirements Repository
The Specialist contributes by:
- Collecting additional country requirements
- Sharing updates
- Supporting the global repository
This aids in continuous improvement and maintaining an accurate database.
11. Continuous Improvement and Compliance Initiatives
The role requires active participation in:
- Innovation initiatives
- Process simplification activities
- Compliance adherence
- Technology adoption
This ensures clinical trial submissions continue to evolve with regulatory expectations. Bristol Myers Squibb Hiring for Submissions Specialist
Educational Qualifications
Candidates must have:
- BA/BS degree
- Preferred fields: Science or Technology
Experience Requirements
- 1–2 years of experience in the pharmaceutical or clinical research industry
- Experience in regulatory submissions or clinical trial operations is highly preferred
Key Competencies
Candidates are expected to possess:
- Good understanding of regulatory submissions for non-US clinical trials
- Ability to communicate questions, challenges, and solutions effectively
- Capability to support cross-functional teams
- Participation in study team meetings
- Ability to work under supervision with attention to detail
- Proficiency with CTMS, tracking systems, and Excel tools
On-Site Work Model
BMS follows a structured occupancy model:
- Site-Essential: 100% onsite
- Site-by-Design: Hybrid (at least 50% onsite)
- Field-Based: Travel-based
- Remote-by-Design: Fully remote with occasional travel
The Specialist role may fall under site-by-design, requiring regular onsite presence for collaboration, documentation handling, and coordination. Bristol Myers Squibb Hiring for Submissions Specialist
Commitment to Inclusion and Accessibility
BMS is committed to:
- Reasonable accommodations during recruitment
- Equal Employment Opportunity compliance
- Employee well-being
- Transparent and inclusive workplace practices
Applicants with disabilities can request adjustments at any stage of the recruitment process.
Important Note on Eligibility
BMS encourages all aspiring candidates to apply even if they don’t meet every qualification. The company values diverse perspectives and recognizes that talent can grow with opportunity. Bristol Myers Squibb Hiring for Submissions Specialist
Key Box: Specialist – Clinical Trial Submissions Overview
| Category | Details |
|---|---|
| Job Title | Specialist |
| Location | Hyderabad, Telangana |
| Company | Bristol Myers Squibb |
| Job Type | Full Time |
| Requisition ID | R1596499 |
| Experience | 1–2 years (Pharma preferred) |
| Qualification | BA/BS in Science or Technology |
| Key Skills | CTA documentation, CTIS, regulatory submissions, tracking systems |
| Work Model | Onsite / Hybrid (as per role category) |
| Core Functions | CTA dossier prep, coordination, tracking, compliance |
How to Apply for Bristol Myers Squibb Specialist Job
Interested and eligible candidates can apply directly through the official Bristol Myers Squibb careers portal. Bristol Myers Squibb Hiring for Submissions Specialist
Steps to Apply:
- Visit the BMS official careers website
- Search for Job ID: R1596499
- Open the listing for “Specialist – Hyderabad”
- Review responsibilities and requirements
- Click on Apply
- Create or log in to your BMS career account
- Fill in the required details and upload your resume
Candidates should ensure their resume highlights:
- Experience in clinical trial submissions
- Coordination and documentation skills
- Knowledge of CTA processes
- Familiarity with CTMS or tracking tools
Once submitted, the BMS recruitment team will review your application and reach out if shortlisted. Bristol Myers Squibb Hiring for Submissions Specialist
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