Bristol Myers Squibb hiring Clinical Submission Specialist in Hyderabad

Submission Specialist Vacancy in Hyderabad | BMS

Bristol Myers Squibb hiring Submission Specialist in Hyderabad. BA/BS degree, 1–2 years experience. Apply now for pharma regulatory role.

Bristol Myers Squibb (BMS) is hiring a Submission Specialist at its Hyderabad, Telangana location. This role sits at the core of global clinical trial execution and regulatory compliance. It is designed for professionals who understand how accurate, timely regulatory submissions directly impact patient access to innovative therapies. If you have early experience in pharmaceutical regulatory operations and want exposure to global clinical trials, EU CTR processes, and cross-functional study teams, this position offers strong long-term career value.

Company Overview

Bristol Myers Squibb is a global biopharmaceutical company known for advancing science in areas such as oncology, immunology, cardiovascular disease, and cell therapy. The organization operates with a single mission: transforming patients’ lives through science. BMS consistently invests in clinical research infrastructure, regulatory excellence, and employee development, making it one of the most respected names in the pharmaceutical and biotechnology industry.

Working at BMS means contributing to high-impact clinical development programs that move from protocol design to regulatory approval across multiple countries. The company is recognized for strong compliance culture, robust standard operating procedures, and deep collaboration between regulatory affairs, clinical operations, medical, safety, and quality teams. This role in Hyderabad supports global studies and provides exposure to international regulatory frameworks, including EU Clinical Trial Regulation and CTIS.

Job Role & Responsibilities

The Submission Specialist plays a critical operational role in managing clinical trial application (CTA) documentation and ensuring submissions are accurate, compliant, and delivered on time. The position requires strong coordination skills, attention to detail, and a working understanding of global regulatory submission processes.

Key responsibilities include:

• Managing the signing and coordination of clinical trial documentation such as powers of attorney, with the ability to handle multiple signings in parallel.
• Supporting the Submission Senior Specialist or Manager in CTA preparation for initial submissions, study start-up activities, protocol amendments, end-of-trial documentation, and clinical study report distributions.
• Preparing and distributing global Clinical Trial Application dossiers and substantial amendments to country applicants and CROs for submission to Ethics Committees and Health Authorities.
• Preparing and maintaining required data within CTIS for EU Clinical Trial Applications and subsequent modifications under EU CTR.
• Ensuring consistency of CTA content across programs, studies, and participating countries.
• Participating in program- and study-level CTA tracking meetings to manage timelines, submission quality, and regulatory expectations.
• Liaising with internal stakeholders such as Clinical Supply Operations, Operations Leads, Protocol Managers, Medical Monitors, Safety, Quality, and Regulatory teams to ensure compliance with BMS SOPs and global regulatory guidelines.
• Using submission planning and tracking systems such as Veeva Regulatory Information Management systems to track submissions, approvals, and regulatory milestones.
• Escalating risks, trends, or issues that may impact study approval timelines or execution to senior regulatory and study leadership.
• Contributing to the Global Country Requirements Repository by collecting, maintaining, and sharing country-specific regulatory requirements.
• Supporting process improvement initiatives aimed at innovation, simplification, and efficiency in regulatory submission workflows.
• Coordinating updates across studies within a program and supporting continuous improvement and compliance initiatives.
• Effectively using CTMS, tracking systems, and Excel-based trackers to generate regulatory reports and monitor submission status.

This role directly supports timely clinical trial approvals, which in turn accelerates patient access to investigational and approved medicines.

Eligibility / Qualifications

Educational Requirements

• Bachelor’s degree (BA or BS)
• Preferred background in science or technology disciplines

Relevant courses include:
B.Pharm, M.Pharm, Pharm.D, BSc Life Sciences, BSc Biotechnology, BSc Microbiology, BSc Biochemistry, MSc Life Sciences, MSc Biotechnology, MSc Clinical Research, MSc Regulatory Affairs, Biomedical Sciences, Pharmaceutical Sciences

Experience Requirements

• 1 to 2 years of experience in the pharmaceutical, biotech, or clinical research industry
• Exposure to regulatory submissions or clinical trial documentation is strongly preferred

Key Competencies

• Working knowledge of regulatory submission requirements for non-US clinical trial applications
• Understanding of CTA package content and submission lifecycles
• Ability to identify issues early and communicate questions with proposed solutions
• Strong coordination and documentation skills
• Ability to work under supervision while managing multiple parallel activities
• Comfortable participating in cross-functional study team meetings
• Proficiency with regulatory tracking systems, CTMS platforms, and Excel reporting tools

Location & Salary

• Job Location: Hyderabad, Telangana, India
• Work Model: Site-by-design or site-essential, with defined onsite requirements based on role responsibilities
• Salary: Not disclosed by the employer; compensation is competitive and aligned with industry standards for regulatory affairs and clinical research roles

BMS offers a comprehensive benefits package, including health coverage, wellness programs, career development resources, and flexible work policies that support work-life balance.

Application Process

Interested candidates should apply directly through the official Bristol Myers Squibb careers portal.

Apply here: https://jobs.bms.com/careers/job/137477719241

BMS encourages candidates to apply even if they do not meet every requirement. The company values potential, learning ability, and diverse perspectives

FAQs

Who can apply for this Submission Specialist role?

Candidates with a BA or BS degree in science or technology-related fields and 1–2 years of pharmaceutical or clinical research experience can apply.

Is this role suitable for freshers?

This role is not designed for complete freshers. Candidates should have at least some industry experience, preferably in regulatory submissions or clinical trial support.

Is experience with EU CTIS mandatory?

Prior experience with CTIS is beneficial but not mandatory. BMS provides structured training and support for EU CTR processes.

What type of regulatory work is involved?

The role focuses on Clinical Trial Applications, amendments, regulatory documentation coordination, and submission tracking for global clinical trials.

Is the position remote?

No. This is an onsite or hybrid role depending on occupancy classification. Onsite presence is considered essential for collaboration and compliance.

How does this role support long-term career growth?

Experience in global regulatory submissions, CTA lifecycle management, and cross-functional coordination provides a strong platform for advancement into senior regulatory and clinical research roles.

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Category	Details
Company	Bristol Myers Squibb
Vacancies	Not Disclosed
Required Education	BA/BS in Science or Technology (Pharma/Life Sciences preferred)
Experience	1–2 years pharmaceutical or clinical research experience

Tagged as: Pharma Jobs in Hyderabad