Senior Director, Regulatory Operations

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Bristol Myers Squibb

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Biotechnology • Pharmaceuticals

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

10,000+ employees

Founded 1887

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• 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.

🎯 Requirements

• 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

• Medical, pharmacy, dental and vision care. • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). • Financial well-being resources and a 401(K). • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. • Parental, caregiver, bereavement, and military leave. • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. • Other perks like tuition reimbursement and a recognition program.