Senior Manager I, Global Regulatory Sciences - CMC

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.

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Position Summary

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product’s lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.

• The GRS-CMC Senior 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 and background packages (including participating / leading HA meetings with support); and/or post-approval submissions. In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS), Global Product Development and Supply (GPS) and/or Cell Therapy Development Operations (CTDO). The GRS-CMC Senior Manager I will assess Manufacturing Change Controls for global impact and guide technical teams on practical aspects of global change management.
• Duties/Responsibilities
• Support project teams (e.g. TPT / CMC, GRT, TTT, MLT, GO Team, etc.) for pipeline products from development through completion of post-marketing commitments and relevant lifecycle management projects driven by research, such as pediatric formulations and line extensions in close partnership with supervisor
• Provide strategic CMC regulatory expertise for development project teams in close partnership with supervisor
• Provide strategic input to development & GO teams to mitigate drug supply issues in close partnership with supervisor
• Interpret global regulations and guidance
• Identify, communicate and propose resolution to routine issues
• Participate in product fact finding meetings with supervision
• Interface with the Health Authorities for CMC submissions and CMC-related issues, with guidance and oversite from supervisor
• Identify, communicate and propose resolutions to routine/complex issues
• Communicate with project teams; 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
• Ensures the necessary updates are provided to team leaders (CMCL, GRL, Line manager etc.)
• Support the preparation of CMC policies and procedures
• Utilize electronic systems for dossier creation and tracking
• Participate in/lead teams to assess and educate on global regulatory landscape (e.g., review new policy for comment) and determine impact on global regulatory strategy
• Looks for opportunities for continuous improvement in processes and technology solutions
• Ensure Regulatory Compliance and Data Integrity: Accountable for the accurate and timely entry of regulatory information within designated timeframes for assigned products into the Regulatory Information Management system, fostering a culture of quality and compliance across the organization
• Reporting Relationship Associate Director, Director or Senior Director, Global Regulatory Sciences - CMC

Qualifications

• Minimum BA/BS Degree
• 3-5+ years pharmaceutical or related experience (min BA/BS). 2+ years CMC regulatory or related experience