Sr. Director, Global Regulatory Strategy Lead - CDx

Description

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.

Duties & Responsibilities

• 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 awareness of regulatory changes and milestones


• Support preparation for regulatory meetings, advisory committees, and inspections with cross-functional alignment


• Act as deputy to the PG Head in governance forums and represent GRA on major strategic initiatives

Requirements

• Advance degree (MS/PharmD/PhD/MD) in life sciences, biomedical engineering, or related discipline required


• 10+ years experience in regulated pharmaceutical industry (biologics or small-molecule)


• Experience in CDx codevelopment and US/EU submissions; proven leadership of cross-functional and partner teams. 


• Demonstrates deep organizational knowledge, extensive internal networks, and strong command of SOPs, working instructions, and global regulatory guidance


• Expert in regulatory science, with comprehensive understanding of global requirements, emerging standards, and regulatory strategy. Provides influential input on key documents, challenges, and decision points


• Highly skilled in the regulatory process and drug development, able to interpret complex scientific data and guidelines to craft well‑reasoned, compliant, and innovative regulatory solutions


• Translates regulatory guidance into strategic proposals, proactively advising on approaches to address new issues and accelerate development where possible


• Proficient in key software tools and open to adopting new technologies


• In-depth RA expertise, gathering and interpreting regulatory intelligence to guide strategy, contribute to TA-specific insights, and support RIN assessments


• Leads HA interactions, applying strong negotiation and influencing skills

Eligibility Requirements:
 

• Must be legally authorized to work in the United States without restriction


• Must be willing to take a drug test and post-offer physical (if required)


• Must be 18 years of age or older

Compensation

The base salary range for this position is $220,000 to $350,000.   The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements.  We continuously review market data and may adjust salary ranges as needed in the future.  Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law. For an overview of our benefits please click here.