Regulatory Affairs Associate Director, Globalization (Registrations)

About the role

The Regulatory Affairs Associate Director, Globalization is responsible for alignment and execution of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across Business Unit (BU), Regional, and Central teams. This position requires technical expertise and a proven track record of successful registration strategies with a global mindset, leveraging global experience, standards, and intelligence. The role requires a significant understanding of the Regulatory function and its associated activities, as well as previous leadership of a diverse team, with the ability to coach, mentor, and lead.

This role is based at our Franklin Lakes, NJ Headquarters, with approximately 25% US and international travel required. BD prioritizes on-site collaboration, requiring a minimum of 4 days of in-office presence per week for most roles.

Responsibilities

• Provide centralized regulatory intelligence and governance related to global product registration to interpret and execute on global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access.
• Own and standardize global regulatory registration processes, driving consistency, efficiency, and scalability across regions while allowing appropriate flexibility to meet local regulatory needs.
• Act as a strategic partner to Business Units and Regional Regulatory leaders, enabling aligned execution of regulatory strategies through tools, processes, and best-practice sharing.
• Coordinate and network across Business Units, Regions, Central RA, and other functions to influence, manage, and/or oversee global registration processes and programs, identifying areas for improvement.
• Train, develop, and manage a highly effective regulatory team through direct and indirect reporting structures.
• Work across business units and regional RA operations teams to harmonize key processes, escalate issues, and build communications channels across RA.
• Aid business units and functional groups in the creation of risk mitigation plans and solutions.
• Work across regulatory affairs teams to identify common pain points and potential solutions.
• Drive BD’s global regulatory strategy and vision in collaboration with regional leads, business leads, and functional stakeholders.
• Stay apprised of global regulatory policy topics related to global product registration.

Requirements

• Bachelor’s degree in science, engineering, or technology discipline required.
• Minimum 12 years of experience in Regulatory Affairs.
• Minimum 8 years of experience in a management role.

Preferred Qualifications

• Master’s degree in business, management, or technology-related field.
• Experience in both Business and Regional roles.
• Regulatory Affairs Certification (RAC).

Skills

• Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of assigned 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 thorough regulatory assessments 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 based on risk assessment.
• Communication Skills: Able to present problems and recommendations to senior management effectively and accurately. Acts as a facilitator for small and large groups and works with a diverse group of colleagues.
• Action Oriented: Demonstrates a significant bias for action to execute key objectives while actively seeking other opportunities to contribute.
• Courage & Independence: Able to escalate issues as needed and make key decisions within area of focus.
• Composure: Responds constructively in stressful situations and drives to the root cause of potential issues.
• Flexibility: Adapts plans to changing priorities, modeling and practicing key principles of change management.
• Process Effectiveness: Independently identifies efficient ways to simplify and implement complex processes and reaches out for help where needed.
• Process and Service Acumen: Thorough understanding of service-related processes and service engineering with the 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 toward an intended course of action.
• Dealing with Ambiguity: Able to assess risk, competing needs, and priorities to develop solutions.
• 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.

Physical Demands

• 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.

Pay

Salary range: $183,800.00 - $294,100.00 USD annually.

Benefits

• Compensation: Competitive compensation package, including annual bonus and potential discretionary long-term incentive (LTI) bonus.
• Health and Well-being:
  • Medical, dental, and vision coverage
  • Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)
  • Hospital Care Insurance, Critical Illness Insurance, Accidental Injury Insurance
  • Life and AD&D insurance, Short-term and Long-term disability coverage
  • Long-term care with life insurance
  • Well-being resources: Anxiety management, wellness incentives, sleep improvement, diabetes management, virtual physical therapy, emotional/mental health support, weight management, gastrointestinal health, substance use management, musculoskeletal surgery, cancer treatment, and bariatric surgery benefits
• Retirement and Financial Well-being:
  • BD 401(k) Plan and 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
  • Adoption assistance, Backup day care and eldercare, Support for neurodivergent adults/children/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
  • Bereavement, Military, Personal, Family and Medical (FML), Jury and Witness Duty leaves