Senior Manager I-Global Regulatory Sciences-CMC

1 month ago

Hyderabad, Telangana, 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.

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: .

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.

#HYDDD #LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through scienceTM , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

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 . Visit 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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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