Regulatory Affairs Senior Manager, Regulatory Information & Content Management
Becton Dickinson
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Upgrade to Pro — $25/moBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
The Senior Manager, Regulatory Information & Content Management is responsible for developing, executing, and maintaining the global Regulatory Affairs strategy and roadmap for regulatory information, regulatory content, and the digital platforms that support their management across Business Units and Regions, in alignment with the broader Digital RA strategy and with specific responsibility for the Regulatory Information Management System (RIM).
This role leads the Regulatory Information and Content Management components of the comprehensive Digital RA roadmap and portfolio, improving the accessibility, connectivity, quality, reuse, traceability, and lifecycle management of regulatory information and content and enabling more effective regulatory execution and data-driven decision-making.
The Senior Manager provides strategic and operational leadership for assigned Regulatory Affairs platforms and capabilities, including Regulatory Information Management and systems supporting regulatory document and submission management. The role leads development and execution of the Regulatory Content Management strategy, establishing the capabilities and governance necessary to make authoritative regulatory content findable, connected, reusable, traceable, and suitable for emerging AI-enabled regulatory use cases.
The Senior Manager partners with SMEs and stakeholders across Central Regulatory Affairs, Business Units, Regions, TGS, Quality, and other functions to identify user and business needs and translate them into scalable information, content, and platform capabilities.
Through effective communication, cross-functional collaboration, and problem-solving, the Senior Manager partners with the Senior Director, RA Digitalization, and other leaders to advance the Digital RA strategy, identify transformative opportunities, and lead high-impact initiatives that improve regulatory effectiveness and strengthen BD’s quality standards and customer trust.
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Primary Responsibilities:
· Build Cross-Functional Partnerships: Partner with TGS, ISC, Quality, Central Regulatory Affairs, Business Units, Regions, and other stakeholders to design, implement, operate, and continuously improve scalable information, content, and platform capabilities.
· Define Goals and Performance Measures: Establish measurable goals and outcomes for the Regulatory Information and Content Management portfolio and monitor platform and capability performance, adoption, information and content quality, user experience, and business value.
· Lead Platform and Capability Optimization: Identify and implement opportunities to improve the flexibility, scalability, usability, integration, and operational effectiveness of assigned platforms and related business processes.
Regulatory Information and Content Strategy
• Lead the Regulatory Information and Content Management Strategy: Define the global strategy and future-state capability model for managing regulatory information and content across its lifecycle, including the relationships among RIM, document and submission management, authoritative content sources, and related digital capabilities.
• Establish Regulatory Information and Content Architecture: Define business requirements and governance expectations for information models, taxonomy, metadata, classification, relationships, ownership, lifecycle, traceability, and authoritative sources.
• Enable Regulatory Content Discovery and Reuse: Lead capabilities that allow regulatory users to discover, retrieve, contextualize, and, where appropriate, reuse approved regulatory content, prior submissions, regulatory correspondence, and supporting evidence.
• Connect Regulatory Information and Content: Advance integration between structured regulatory information and unstructured regulatory content so content can be understood in the context of products, markets, registrations, submissions, regulatory activities, and health-authority interactions.
• Improve Information and Content Quality: Establish appropriate ownership, stewardship, quality expectations, and performance measures to improve the completeness, consistency, usability, and reliability of regulatory information and content.
• Enable AI-Ready Regulatory Information and Content: Establish the information architecture, quality, governance, metadata, and content management foundations necessary to support responsible AI-enabled capabilities, including intelligent search, retrieval, comparison, impact assessment, decision support, and AI-assisted content development.
• Partner on AI-Enabled Regulatory Capabilities: Partner with Regulatory AI Enablement and Data Products leadership, TGS, SMEs, and process owners to develop and scale AI-enabled capabilities that use trusted regulatory information and content while maintaining appropriate regulatory, quality, privacy, security, and governance controls.
SDLC and Platform Governance
Supervision and Budgetary Responsibility:
Minimum Requirements:
Preferred Qualifications:
Knowledge and Skills:
Physical Demands: (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:
Health and Well-being Benefits
Other Well-being Resources
Retirement and Financial Well-being
Life Balance Programs
Other Life Balance Programs
Leave Programs
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
$172,000.00 - $275,200.00 USD AnnualExplore related positions you might be interested in
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