Submission Manager

6 months ago

Hyderabad, India Bristol Myers Squibb Full time

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 rich in diversity. Take your career farther than you thought possible.

BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation.


Position Summary 
The Manager 1 manages and coordinates the timely, compliant, and accurate delivery of submission documents and dossiers to health authorities.


Position Responsibilities

• Provides advice regarding regulatory and submission requirements, dossier content, and format using in-depth knowledge of eCTD submission production.
• Supports the execution of the Global Submission Plan through collaborating with team members and vendors.
• Tracks progress of all components for submission to Health Authorities.
• Independently facilitate submission team meetings
• Interacts with responsible parties to aid in ensuring that components are received in a timely manner and provide direction to assure quality results are produced.
• Supports research for legal due diligence activities, document and submission management for acquisitions, partnerships and divestitures, assisting in internal audits and regulatory agency inspections.
• Attend submission team and kick off meetings, represent SM, drive submission publishing timelines.
• Facilitate Initial IND Kick off meeting submission.
• Coordinate IND, NDA, BLA and Orphan Drug Annual Reports.
• Other miscellaneous regulatory operational activities.
• Develop/Update job aid documents for departmental process.
• May facilitate in focused projects related to their scope of work.
 

Degree Requirements
BA/BS degree, science / technology field preferred

Experience Requirements
5+ years relevant submissions experience


Key Competency Requirements
• Proficient knowledge of global regulatory practices, submission guidelines and requirements.
• Identifies and resolves issues with the assistance of Sr. team members.
• Collects, collates, and integrates information for solution development, decision-making, and implementation.
• Generates alternative solutions by weighing risks and considering dependencies.
• Proficient in the English language both written and oral, and able to communicate effectively in written form with non-English speakers. 
• Delivers engaging and effective presentations of increasing complexity. 
• Applies basic knowledge of project management methodologies, tools, and templates and assesses information needed to effectively manage projects of increasing complexity from start to finish.
• Defines project objectives, priorities, timelines, and metrics; tracks progress and communicates status; secures needed resources.
• Drives communication within the project team to ensure awareness of risks, issues, and dependencies and collaboration for effective completion of defined deliverables. 
• Applies critical thinking skills to daily workload decisions, in alignment with group/company objectives.
• Proposes and implements alternative solutions for submission and/or project related situations.
• Understand stakeholder needs, priorities, working processes, and activities and builds collaborative relationships.
• Solid understanding of desktop application software suites, including effective troubleshooting skills. 
• Knowledge and experience with computer systems in an R&D environment.

#HYDDD

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