Regulatory Affairs Senior Manager, Regulatory Information & Content Management

• Provide Regulatory Affairs business leadership and governance for SDLC activities associated with assigned platforms and capabilities, ensuring appropriate requirements, testing, validation, deployment readiness, and lifecycle controls.
• Ensure appropriate business involvement in test strategy, test planning, user acceptance testing, performance qualification, and implementation readiness.
• Review and provide business approval of applicable SDLC deliverables, ensuring alignment among user requirements, business processes, system design, intended use, and applicable controls.
• Ensure appropriate business participation in regression testing for platform enhancements, periodic releases, and infrastructure upgrades.
• Partner with Quality and technology organizations to establish fit-for-purpose CSV and validation strategies for assigned regulatory platforms and enhancements.
• Establish appropriate governance for platform demand, enhancement prioritization, release planning, issue escalation, and lifecycle management.

• Lead assigned Regulatory Information and Content Management resources, including goal setting, coaching, talent development, performance management, resource planning, and capability development.
• Manage assigned operating budgets and contribute to business cases, investment planning, resource forecasts, and project and technology funding recommendations for the Regulatory Information and Content Management portfolio.
• Provide direction to cross-functional project teams, business SMEs, contractors, and external partners supporting assigned platforms and initiatives.

• Bachelor's degree in science, engineering, technology, information management, business, or a related discipline.
• Minimum of

in Regulatory Affairs, Quality, regulatory operations, information/content management, digital technology, business systems, or a related discipline.

• Demonstrated experience leading Regulatory Information Management, content management, document and submission management, regulatory product information management, or a related enterprise digital capability in a regulated environment.
• Demonstrated experience leading and developing employees and/or globally distributed teams.
• Demonstrated experience partnering with technology organizations to implement, govern, enhance, or maintain business systems.
• Experience translating regulatory and business needs into information, content, process, data, or technology requirements.
• Experience leading complex, cross-functional initiatives in a global or matrixed organization.
• Working experience with applicable SDLC, validation, data integrity, and regulated-system controls.

• Master's degree in business, management, information science, technology, regulatory affairs, or a related discipline.
• Experience within the medical device or life sciences industry.
• Experience serving as a business owner or capability leader for an enterprise regulatory platform.
• Experience with RIM, document and submission management, structured product information, regulatory content management, taxonomy, metadata, or information governance.
• Experience managing budgets, vendors, external partners, or globally distributed resources.
• Regulatory Affairs Certification or a relevant information, data, project, or technology credential.

• Regulatory Information and Content Management: Demonstrates strong understanding of regulatory information management, document and submission management, content lifecycle management, metadata and taxonomy, information governance, and emerging approaches for connecting structured and unstructured regulatory information. Understands how well-governed regulatory information and content enable analytics, automation, and responsible AI-enabled capabilities.
• Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
• Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.
• Decision Quality: Accurately assesses risk and clarifies ambiguous situations to make good decisions, developing alternatives with clearly documented consequences for each possible course of action.
• Communication Skills: Skilled facilitator for small and large groups and organizations, adapting content and style to engage audiences, and able to articulately respond to impromptu comments and questions.
• Action Oriented: Demonstrates a significant bias for action to execute key objectives, while actively seeking other opportunities to contribute.
• Courage & Independence: Seeks out and selects stimulating work with challenges, increasing scope and responsibilities.
• Composure: Responds constructively in stressful situations and effectively calms others while taking action to resolve the root cause of the situation causing stress.
• Flexibility: Adapts plans to changing priorities, modeling and practicing key principles of change management.
• Process Effectiveness: Independently identifies the most efficient way to simplify and implement complex processes.
• Process and Service Acumen: Thorough understanding of service-related processes and service engineering with ability to independently influence organizational direction.
• Organizational Agility: Is cognizant of organizational culture in a matrixed environment and appropriately adjusts personal style to be effective. Builds numerous and beneficial relationships through personal networks, inside and outside the organization.
• Influencing Others: Leverages internal or external experts or third parties to influence others towards an intended course of action. Experienced at using multiple chains of influence to achieve broad organizational acceptance.
• Dealing with Ambiguity: Anticipates the organizational impact of change, rising to the challenge, applying ingenuity, while accepting risk and uncertainty as normal.
• Building Effective Teams: Builds mission-driven, cohesive teams of people, sharing team wins and successes throughout the organization to instill team member value and appreciation.

(if applicable) When work is performed in an office environment the position requires the ability to operate standard office equipment and keyboards. Must have the ability to stand, walk and sit; talk or hear, both in person and by telephone; use hands to finger, handle or feel objects or controls; reach with hands and arms. Ability to travel domestically and internationally approximately 25%.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus
• Potential Discretionary LTI Bonus

Health and Well-being Benefits

• Medical coverage
• Health Savings Accounts
• Flexible Spending Accounts
• Dental coverage
• Vision coverage
• Hospital Care Insurance
• Critical Illness Insurance
• Accidental Injury Insurance
• Life and AD&D insurance
• Short-term disability coverage
• Long-term disability insurance
• Long-term care with life insurance

Other Well-being Resources

• Anxiety management program
• Wellness incentives
• Sleep improvement program
• Diabetes management program
• Virtual physical therapy
• Emotional/mental health support programs
• Weight management programs
• Gastrointestinal health program
• Substance use management program
• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit

Retirement and Financial Well-being

• BD 401(k) Plan
• BD Deferred Compensation and Restoration Plan
• 529 College Savings Plan
• Financial counseling
• Baxter Credit Union (BCU)
• Daily Pay
• College financial aid and application guidance

Life Balance Programs

• Paid time off (PTO), including all required State leaves
• Educational assistance/tuition reimbursement
• MetLife Legal Plan
• Group auto and home insurance
• Pet insurance
• Commuter benefits
• Discounts on products and services
• Academic Achievement Scholarship
• Service Recognition Awards
• Employer matching donation
• Workplace accommodations

Other Life Balance Programs

• Adoption assistance
• Backup day care and eldercare
• Support for neurodivergent adults, children, and caregivers
• Caregiving assistance for elderly and special needs individuals
• Employee Assistance Program (EAP)
• Paid Parental Leave
• Support for fertility, birthing, postpartum, and age-related hormonal changes

Leave Programs

• Bereavement leaves
• Military leave
• Personal leave
• Family and Medical Leave (FML)
• Jury and Witness Duty Leave