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Bristol Myers Squibb
Senior Specialist, Submission ManagementBristol Myers Squibb • PL,Warsaw
Senior Specialist, Submission Management

Senior Specialist, Submission Management

Bristol Myers Squibb • PL,Warsaw
Ponad 30 dni temu
Opis pracy

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Shape How Medicines Reach Patients Worldwide

The Opportunity

What if your workdidn’tjust support submissions… but helped accelerate how innovative therapies reach patients across the globe?

At Bristol Myers Squibb,we’retransforming how regulatory submissions are delivered—making them faster, smarter, and globally aligned. As aSenior Specialist,you’llplay a critical role in driving high-quality submissions and improving how teamsoperatetogether globally.

Your Mission

Own and deliver IND and global regulatory submissions end-to-end, ensuring compliant, high-quality dossiers reach health authorities on time—while driving consistency, efficiency, and operational excellence across submission activities.

What Your Week Might Look Like

  • Leading coordination of submission activities across global teams

  • Partnering with stakeholders to define submission strategy and timelines

  • Managing IND and marketing application submissions from planning through to delivery

  • Tracking progress,identifyingrisks, and ensuring milestones stay on track

  • Executing eCTD publishing and managing submissions via HA portals

  • Working in Veeva RIM andLorenzdocubridgepublishing tool tomonitor, report, and manage content

WhatYou’llDo

  • Drive end-to-end submission management (IND and global applications)

  • Collaborate with cross-functional and global stakeholders to deliver compliant dossiers

  • Manage timelines, risks, and dependencies across submission projects

  • Execute and oversee eCTD publishing activities

  • Maintain submission data, reporting, and tracking in Veeva RIM

  • Coordinate non-eCTD submissions with international teams

  • Ensure consistency across submissions, studies, and regions

  • Contribute to continuous improvement and innovation initiatives

You’llThrive If You

  • Take ownership and proactively drive deliverables

  • Enjoy balancing coordination, execution, and problem-solving

  • Are confident working across global, matrixed environments

  • Have strong attention to detail and organisational skills

  • Are motivated to improve processes and embrace digital tools and automation

Your Background

  • Bachelor’s degree (science or related field preferred)

  • Experience in regulatory submissions (typically 1–3+ years)

  • Understanding of global regulatory requirements and submission processes

  • Exposure to IND, eCTD, or global submissions

  • Familiarity with tools such as Veeva RIM andLorenzedocuBridgepublishingtoolis a plus

  • Strong communicationand stakeholder engagement skills

  • Ability to manage priorities and deliver against timelines

Why This Role is Different

  • Meaningful exposure to global regulatory submissions and health authorities

  • Opportunity to work across multiple regions and therapeutic areas

  • Strong visibility within regulatory and cross-functional teams

  • A chance to improve how submissions are delivered—at scale and with impact

Flexibility

Hybrid role with the option to work remotely up to50% of the time, aligned with business and collaboration needs.

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Senior Specialist, Submission Management • PL,Warsaw