Sr. Director, Global Regulatory Strategy Lead - CDx

The Sr. Director, Global Regulatory Strategy Lead plays a pivotal role in guiding assigned projects throughout product lifecycle through regulatory thought leadership and extensive experience. This role will provide specific strategic and hands‑on regulatory leadership for global development, approval, and lifecycle management of therapeutics, specifically those being codeveloped with CDx/IVD/medical device/SaMD - ensuring timely market access and compliant post‑market performance across the US, EU, and key international markets.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

• Collaborate across all organizational levels and functions, effectively engaging senior stakeholders to drive regulatory success
• Lead complex regulatory projects with strategic, well‑reasoned options and clear arguments to achieve optimal outcomes
• Uphold the highest standards of professionalism, ethics, and compliance
• Develop and execute cutting‑edge global regulatory strategies for complex assets and indications in partnership with RA subteams, RET, and Evidence Teams
• Identify and communicate regulatory risks, opportunities, and innovative pathways to accelerate development and approval
• Support key lifecycle milestones and ensure alignment between regulatory strategy, business goals, and regional requirements
• Anticipate regulatory hurdles and proactively design strategies to overcome them
• Partner with Asset, Evidence, and Global Labeling teams to shape regulatory‑optimized target labels and ensure global labeling alignment
• Provide global input into CCDS content and support regional teams on SmPC/PI development across all lifecycle stages
• Oversee planning, preparation, and execution of major regulatory submissions (INDs, CTAs, MAAs, NDAs, BLAs)
• Support global submission rollout and regional priorities for Rest of World markets
• Lead lifecycle management strategies for marketed products, including post‑approval changes and variations, ensuring continuous compliance
• Serve as a thought leader on emerging regulations, trends, and their impact on strategy; guide teams and adapt plans accordingly
• Provide timely risk/benefit analyses, competitive intelligence, and insights on innovative regulatory pathways
• Represent GRA as an SME in cross‑functional groups, working teams, and external forums
• Define global strategy and goals for Health Authority interactions; guide briefing materials, questions, and meeting execution
• Maintain oversight of local RA activities and responses to HA questions; lead proactive relationships with authorities and external stakeholders
• Provide global regulatory input into critical safety, quality, and HCP communications
• Support internal/external assessments, licensing collaborations, and continuous improvement initiatives
• Lead and mentor regulatory professionals, fostering innovation, strategic thinking, and high‑performing teams
• Ensure appropriate staffing, skill development, and regulatory training across RA subteams
• Resolve escalated issues, provide clear direction, and support development of internal training and knowledge‑sharing programs
• Offer regular, actionable feedback to team members and encourage cross‑functional visibility
• Prioritize personal development, staying current on regulatory trends and emerging technologies (automation, analytics, AI)
• Provide educational support to pharmacy students
• Represent GRA on Evidence Teams, aligning regulatory and development strategies to maximize probability of success
• Maintain strong communication channels with cross‑functional teams, ensuring…