Director, Regulatory Operations
Location
United States
Posted
18 days ago
Salary
$210.6K - $255.2K / year
Bachelor Degree7 yrs expEnglishVault
Job 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.
Job Requirements
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- Minimum of 7+ 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.
- Work-life benefits include: 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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. *Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
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