Senior Submission Manager
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The Submission Manager drives the execution of the Global Submission Plan through collaborating with team members and vendors. They are responsible for tracking the progress of all components for dossier submissions to health authorities. They interact with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced. They assure regulatory guidelines are followed for electronic format, and review both submission ready documents and dossiers for compliance to these guidelines. The Submission Manager demonstrates a strong working knowledge of global regulatory practices and requirements and supports liaisons, CMC, safety, and other regulatory functions as appropriate.
The Submission Manager is the subject matter expert for dossier production and provides advice, mentoring, and guidance with regard to regulatory and submission requirements, submission strategies, dossier content, and format. Submission Managers are also key players in researching for legal due diligence activities, document and dossier management for acquisitions, partnerships and divestitures, assisting in regulatory agency inspections, and other miscellaneous regulatory operational activities (e.g. US export waivers, translation document management, maintenance of US PDUFA products/establishment lists, etc.).
- Working knowledge of global regulatory practices, electronic submission guidelines and requirements
- Ability to lead multi-functional submission teams and track progress of dossier components to ensure timely execution of submissions.
- Ability to interact and negotiate with outside vendors on Global Dossier Management matters.
- Must exhibit strong attention to detail, have good organization, communication, and collaboration skills, and seamless multi-tasking abilities to be able to work simultaneously on multiple projects.
- Needs to be able to effectively adjust plans to deal with constant change and the challenges that come with it. Must be able to think in a clear, decisive manner remaining calm under submission timeline pressures and adverse conditions.
- Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, Lync, Access, Documentum, eCTD viewers and web based applications) and be technically savvy with such systems.
- Be able at times to work long hours; sometimes including nights, holidays and weekends.
- B.S. in a relevant field (Science or Computer Science preferred) with greater than 7 years of pharmaceutical industry and drug development experience, or an M.S. in a relevant field with a minimum of 7 years of pharmaceutical industry experience.
- A minimum of one year in regulatory affairs/operations/submission management.
- Understanding of submission principles is required. Level will commensurate with knowledge and experience.
- Technically savvy
- Flexibility, proactive, attention to detail, demonstrated accountability for deliverables, and proven ability to work in a fast-paced team environment or independently is expected