Regulatory Affairs Strategist, Digitalization - Advertising & Promotion

• Provide Regulatory Affairs business governance and oversight for application configuration, business-controlled data, user access, and role design, in partnership with technology and operational teams.
• Identify data quality and integrity risks, lead or coordinate appropriate resolution and escalation, and identify recurring application issues and opportunities for systemic improvement.
• Lead Power User forums, Change Control Board activities, and other application governance mechanisms to facilitate effective communication, prioritization, and decision-making.
• Establish and monitor relevant application metrics to evaluate platform performance, effectiveness, data quality, adoption, and opportunities for continuous improvement.
• Develop business impact assessments, resource considerations, and cost and timing estimates, as appropriate, for proposed enhancements and digital initiatives.

• Author, review, and approve applicable business-owned application documentation, including SOPs, work instructions, and other controlled documentation, partnering with the Global Ad/Promo Process Owner and relevant Quality and Regulatory stakeholders to ensure alignment with approved business processes and requirements.
• Establish and maintain the application training strategy and associated training materials.
• Coordinate the development and maintenance of learning content, including eLearning modules, work instructions, and other user-support resources.
• Drive user readiness, adoption, and effective use of the platform across Business Units and Regions.

• Lead Regulatory Affairs business activities associated with the Software Development Lifecycle and Computer Systems Validation for Advertising & Promotion digital platforms.
• Lead business test planning and execution, including Performance Qualification (PQ), User Acceptance Testing (UAT), and applicable regression testing.
• Serve as business test lead and coordinate the development, review, execution, and approval of business test scripts and associated evidence.
• Review and provide business input and approval for applicable SDLC and validation deliverables.
• Participate in key requirements, design, risk, validation, and release-readiness activities, ensuring alignment among user requirements, business processes, system design, and intended use.
• Provide business and Regulatory Affairs input into CSV/validation strategies for platform enhancements, releases, and infrastructure changes.
• Ensure appropriate business readiness prior to implementation of system changes and enhancements.

• Bachelor's degree in a science, engineering, technology, health-related, or related discipline.
• Minimum of 5 years of progressive experience in Regulatory Affairs, Quality, digital/technology, business systems, or a related function.
• Minimum of 3 years of experience supporting, implementing, or managing business systems within a regulated environment.
• Demonstrated experience partnering with IT or technology organizations to implement and maintain systems following GxP, Computer Systems Validation (CSV), and Software Development Lifecycle (SDLC) standards.
• Experience with business requirements, system enhancements, application testing, release management, and validated system lifecycle activities.
• Experience working in the medical device, pharmaceutical, life sciences, or another regulated industry.

• Master's degree in a business, management, science, engineering, or technology-related field.
• Experience supporting Regulatory Affairs digital platforms.
• Experience with Advertising & Promotion regulatory processes and/or promotional-material management platforms.
• Experience with Veeva or similar regulated content/workflow platforms.
• Experience operating in a global, matrixed organization.

(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 handle objects or controls; and reach with hands and arms.
• Ability to travel domestically and internationally approximately 10-20%.

(if applicable)

• Position follows the applicable BD workplace designation and associated on-site requirements.

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