Associate Director, Dossier Management
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Associate Director, Submission Management, manages and coordinates the timely, compliant, and accurate delivery of submissions to health authorities.
- Drives the execution of the Global Submission Plan through collaborating with team members and vendors.
- Tracks the progress of all components for submissions to health authorities.
- Interacts with and influences responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced.
- Assures regulatory guidelines are followed for electronic format and review of submission ready documents and submission dossiers for compliance to these guidelines.
- Leads projects and other quality improvement initiatives for the department.
- Demonstrates a strong working knowledge of global regulatory practices and requirements and supports liaisons, CMC, Safety, and other regulatory functions as appropriate.
- Subject matter expert for submission production and provides advice, mentoring, and guidance with regards to regulatory and submission requirements, submission strategies, content, and format.
- Key player in researching for due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections
- Other miscellaneous regulatory operational activities (e.g. US export waivers, translation document management, etc.
BA/BS degree, science / technology field preferred experience
7+ years relevant regulatory / submissions experience
Key Competency Requirements
• Expert knowledge of global regulatory practices, electronic submission guidelines and requirements.
• Ability to lead and influence multi-functional submission teams and track progress of submission components to ensure timely execution of submissions.
• Ability to interact and negotiate with suppliers on Global Submission Management matters.
• 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 change and be flexible. Must be able to think in a clear, decisive manner under submission timeline pressures.
• Must be comfortable working in an environment that utilizes electronic docbases, databases, publishing and computer systems (Microsoft Office, Outlook, 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.
Travel Required 5%
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.