Sr. Manager, Regulatory Affairs

Johnson & Johnson Johnson & Johnson · Pharma · New Brunswick, NJ +8

The Sr. Manager, Regulatory Affairs will lead the technology product strategy and delivery for Regulatory Affairs-focused digital capabilities within DePuy Synthes, a new standalone orthopedics company. This role involves owning the end-to-end product lifecycle for regulatory technology platforms, translating regulatory and quality needs into scalable, compliant solutions, and driving the application of AI, advanced analytics, and automation to modernize R&D platforms. The position requires strong collaboration with various stakeholders and ensuring solutions meet global regulatory, quality, and data integrity requirements.

What you'd actually do

  1. Own the end‑to‑end product lifecycle for Regulatory Affairs technology platforms, from strategy and roadmap through delivery, adoption, and optimization.
  2. Partner with Regulatory Affairs, Quality, R&D, Supply Chain, and IT stakeholders to translate business needs into clear product requirements and prioritized backlogs.
  3. Define and maintain a multi‑year product roadmap aligned with regulatory strategy, compliance obligations, and enterprise architecture standards.
  4. Ensure solutions meet global regulatory, quality, and data integrity requirements, including validation and audit readiness.
  5. Lead cross‑functional delivery teams using Agile and product management best practices to deliver value incrementally and predictably.

Skills

Required

  • technology product management
  • IT delivery
  • digital transformation
  • supporting Regulatory Affairs
  • supporting Quality
  • supporting R&D
  • regulated environment
  • medical devices
  • pharmaceuticals
  • life sciences
  • regulated system delivery
  • validation
  • compliance
  • data integrity
  • lead cross-functional, global teams
  • influence without direct authority
  • owning and prioritizing product backlogs
  • owning and prioritizing product roadmaps
  • tied to business outcomes
  • communication skills
  • translate complex technical topics for business audiences

Nice to have

  • regulatory information management (RIM)
  • submission-related platforms
  • Agile / SAFe delivery models
  • enterprise environments
  • managing technology vendors
  • system integrators
  • global regulatory operations
  • health authority interactions
  • data solutions supporting regulatory processes
  • analytics solutions supporting regulatory processes
  • automation solutions supporting regulatory processes
  • Master’s degree (MS, MBA)

What the JD emphasized

  • regulatory environment
  • regulated system delivery
  • validation
  • compliance
  • data integrity

Other signals

  • AI
  • advanced analytics
  • automation
  • digital innovation
  • product lifecycle
  • regulatory technology platforms
  • compliance