Bristol Myers Squibb · 1 month ago
Senior Director, Regulatory Operations
United States
Full-time
Remote
Director/Executive
$242K/yr - $293K/yr
10+ years expBristol Myers Squibb is a leading company in the pharmaceutical industry focused on transforming patients' lives through science. They are seeking a Senior Director of Regulatory Operations to build and manage a team that supports submission planning and regulatory compliance, while also overseeing the implementation of regulatory systems and ensuring adherence to global standards.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
Qualification
Required
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
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 diverse complexity and execute independently from beginning to end
Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing
Strong communication and interpersonal skills
Should be assertive, proactive, professional, and confident
Excellent professional ethics and integrity
Flexibility to adapt in a cross-functional and dynamic environment
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-21
2026-01-20
2026-01-20
Company data provided by crunchbase