Senior Specialist, Submission Management

Location: Uxbridge - GB

Type: Full time

Posted: Yesterday

Requisition ID: R1589311

About Us

Bristol Myers Squibb offers challenging, meaningful, and life-changing work. Join us to be part of innovative projects that transform patient lives and advance careers. We value work-life balance and offer competitive benefits. Learn more at careers.bms.com/working-with-us.

Position Purpose

The Senior Specialist manages the timely, compliant, and accurate delivery of submission documents to health authorities.

Key Responsibilities

• Track, collect, and review submission components.
• Engage with responsible parties for high-quality submissions.
• Facilitate submission team meetings.
• Participate in projects related to submission processes.
• Prepare cover letters, forms, and content plans for various applications.
• Attend team meetings, represent RISM, and ensure timelines are met.
• Coordinate initial IND meetings and submissions.
• Develop and update departmental process documents.
• Manage structures for global submissions.
• Coordinate non-eCTD submissions with the International Regulatory Team.

Qualifications and Experience

BA/BS in science or related field preferred. Relevant submission experience.

Key Competencies

• Knowledge of global regulatory practices.
• Goal-oriented with proactive problem-solving skills.
• Effective communication and stakeholder engagement.
• Project management and prioritization skills.
• Proficiency in desktop software and R&D systems.

We encourage candidates to apply even if their experience doesn’t match all requirements. Your next career move could be life-changing.

Work Environment & Additional Info

Our occupancy model includes onsite, hybrid, and remote roles, with specific requirements per role. We support accessibility and reasonable accommodations. We recommend vaccination against Covid-19 for staff safety. Bristol Myers Squibb is committed to diversity, inclusion, and equal employment opportunities, including for those with criminal records, in accordance with local laws. All data is handled per privacy policies. We are a Disability Confident Employer, supporting individuals with disabilities.