Senior Director, Regulatory Operations

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.

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.

Location: Remote 

Job Responsibilities 

Essential duties and responsibilities include the following.  Other duties may be assigned. 

• Build and manage a Regulatory Operations team to support submission planning, publishing, and lifecycle management. 

• Oversee/lead planning, tracking, publishing, compilation, and archiving efforts in support of regulatory submission activities including INDs, NDAs, BLAs, IND amendments, IMPDs and CTA submissions, EU and Rest of World (ROW) submissions. 

• Lead the implementation and optimization of Veeva Vault RIMs, ensuring alignment with regulatory and business needs.  

• Establish and maintain SOPs, work instructions, and best practices for regulatory operations. 

• Monitor global regulatory operations requirements and ensure compliance with evolving standards. 

• Serve as the primary liaison with publishing vendors, as needed, to ensure compliant electronic submissions. 

• Manage templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and training across functional groups. 

Education and Experience 

• Bachelor’s degree in life sciences or related field; advanced degree preferred. 

• Minimum of 10+ years in Regulatory Operations within the pharmaceutical or biotech industry. 

• Proven experience implementing and managing Veeva Vault RIMs or similar regulatory systems. 

• Strong knowledge of global regulatory submission formats (eCTD, NeeS, paper) and requirements. 

• Demonstrated success in leading submissions across US, EU, and global markets. 

• Experience building and scaling teams in a high-growth, agile environment. 

• Excellent project management, communication, and leadership skills. 

• Ability to thrive in a fast-paced, dynamic setting with shifting priorities. 

Skills and Qualifications 

• Experience with regulatory publishing tools and document management systems. 

• Familiarity with regulatory intelligence platforms and submission tracking tools. 

• Strong understanding of regulatory lifecycle management and compliance frameworks. 

• Excellent written and verbal communication skills. 

• Highly organized, with the ability to multi-task and handle pressure well 

• Meticulous with detail and precision 

• Ability to think through a project or task of