Senior Manager, Global Regulatory Sciences-CMC

The Senior Manager, GRS-CMC 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); &/or post-approval submissions. In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.,

• Support project teams (e.g. TPT / CMC, GRT, TTT, MLT, GO Team, etc.) 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 & GO 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 with the US FDA for CMC submissions and CMC-related issues (either with the USL or directly)


• 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


• Ensures the necessary updates are provided to team leaders (CMCL, GRTL, Line manager etc.)


Degree Requirements

Minimum BA/BS Degree, BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.


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


• Knowledge of CMC regulatory requirements for advanced therapies and/or biologics during development and post-approval.


• Knowledge of pharmaceutical development, including advanced therapies and/ or biologic upstream and downstream processes, analytical methods, and biologic/device combination products.


• Demonstrated ability to develop/maintain strong working relationships cross functional teams, participate on and/or lead multifunctional teams, handle and 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
  
  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.


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. Read more: careers.bms.com/working-with-us