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Senior Manager I-Global Regulatory Sciences-CMC
2 months ago
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 GRS-CMC Sr. Manager I is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating / leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Sr. Manager I will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC Sr. Manager I will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
Key Responsibilities
Support project matrix teams for pipeline products from development through completion of post-marketing commitments & relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions.
Provide strategic CMC regulatory expertise for development project teams.
Provide strategic input to development and commercial teams to mitigate drug supply issues.
Interpret global regulations and guidance.
Identify, communicate and propose resolution to routine issues.
Participate in product fact finding meetings.
Interface (either directly or indirectly) with the US FDA for CMC submissions and CMC-related issues.
Communicate with project teams; in particular with regards to technical issues that may impact regulatory submissions, strategy, or success.
Provide technical teams insight into regulatory health authority expectations.
Identify potential risks & help technical teams to formulate mitigation strategies to ensure regulatory success.
Ensure the necessary updates are provided to team leaders.
Qualifications & Experience
Minimum BA/BS Degree
3-5+ years pharmaceutical or related experience. 2+ years CMC regulatory or related experience.
Knowledge of global CMC regulatory requirements for pharmaceutical small molecules and/or biologic products during development and post-approval.
Demonstrated ability to develop/maintain strong working relationships with cross functional teams, participate on and/or lead multifunctional teams, and handle/prioritize multiple projects and work independently.
Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
Ability to interpret global regulations and guidance documents.
Strong oral and written skills.
Proficient with electronic systems.
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