Job Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren\xe2\x80\x99t 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\xe2\x80\x99ll 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 Operations Regulatory Services Senior Manager will collaborate with stakeholders across functional area to enhance business processes and provide strategic input for the Information Technology (IT) systems and processes utilized for change control, Regulatory Information Management (RIM), and dossier authoring, publishing and viewing systems.

Key Responsibilities

• Provide subject matter expertise on change control, RIM, and dossier authoring, publishing and viewing systems.
• Based on strong knowledge of United Stated (US) regulations and submissions, define the strategy to remediate issues (e.g. creating the required planned US submissions in the RIM system) where GRS- CMC Operations has the role of the US Country Regulatory Manager (CRM).
• Oversee routine transactions performed in the RIM system (e.g. uploading Health Authority correspondences and queries, tracking of Health Authority commitments).

• Provide expertise to CMC Data Quality issues to support the accuracy of data in the RIM system

• Point of contact to address/resolve issues related to the regulatory CMC authoring system and serve as an interface to the CMC Submission Management group
• Lead within the GRS-CMC department for the IDMP (Identification of Medicinal Products) initiative. Serve as IDMP Lead Data Steward for CMC attributes
• Serve as the Administrator and/or Coordinator of Multi Product change controls.
• Subject Matter Expert for routine / non-product submissions to FDA, including but not limited to: Establishment Registration and Drug Listing (ERDL), National Drug Code (NDC) Labeler Code, Medical Device Registration, Blanket No Change Certifications, Listings, FDA Cares submissions, and Biologics Lot Distribution Reports. Lead the cross -functional planning, coordination and receipt of data from non-GRS functions, and draft then publish submissions to FDA within required timelines.
• Perform ERDL Impact Assessments for commercial change controls, and create / complete Change Actions to perform ERDL submissions
• Author and review procedural documents

Qualifications & Experience

• Minimum BA/BS degree
• Minimum of 2 - 4 years pharmaceutical or related experience. Minimum of 1 year CMC regulatory or related experience.
• Strong oral and written communication skills with the ability to effectively impact project teams with strategic solutions to issues. Participate in and/or lead multifunctional teams.
• Ability to interpret global CMC regulations and guidance, including proficient use of resources to stay current with emerging standards and regulations.
• Proficient navigation of electronic systems, including formatting and electronic management of data and information.
• Manage and prioritize multiple projects and complex assignments independently.

• Establish effective working relationships with business units and key business partners to achieve assigned objectives.
• Analyze and measure the effectiveness of existing business processes within the GRS-CMC department and identify opportunities to improve business practices and processes to maximize resources.

#HYDDD #LI-Hybrid

If you come across a role that intrigues you but doesn\xe2\x80\x99t 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 \xe2\x80\x9cTransforming patients\xe2\x80\x99 lives through science\xe2\x84\xa2 \xe2\x80\x9d, 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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 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.

Bristol-Myers Squibb