Director, Regulatory Affairs US Product Group - CRM; Hybrid

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 several 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.
For assigned development projects and US marketed products, the Director, US Product Group Regulatory Affairs will provide expert US regulatory leadership to the global and US cross-functional teams throughout the product lifecycle. This role will provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance. As a member of the Regulatory Excellence Team, the position holder will provide US regulatory input into the Global Regulatory strategy for assigned projects and represent US RA on US cross-functional teams.

Regulatory Professionalism:

• Seamlessly interacts and collaborates effectively at all levels organization (local and global) within RA and across functions.
• Advocates to effectively, efficiently and proactively drives project goals, presenting well-grounded, strategically thought-through options and arguments to independently achieve success regulatory outcomes.
• Maintains the highest stands of professionalism, ethics, and regulatory compliance.

Regulatory Excellence Team (RET) and Intra-RA Project Responsibilities:

• Recognized expert in contributing a broad range of US operational and strategic perspectives to Regulatory Excellence Team (RET).
• Actively collaborates with RET to align regulatory strategies with product development plans.
• Proactively provides regulatory input and options during all stages of product development to ensure potential challenges and requirements are addressed from the start.
• Jointly problem-solves to address issues and find innovative solutions that align with business objectives while meeting regulatory standards. Shares successful use cases, where applicable.
• Provides regular updates on US regulatory milestones and their impact on the overall project timelines.
• Presents or supports review of US-specific regulatory topics to Regulatory Expert Group (REG), as appropriate.
• Independently ensures US RA contributions to all local and global project related documentation (e.g., Global RA Strategy, Risk Assessments, Labeling) are clear, complete and accurate, taking on leadership of the content/information, as appropriate.

Other Regulatory Contributions:

• Provides US regulatory leadership in the preparation, content, and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with input/guidance from management, GRSL, US Legal, and PSPV, as appropriate.
• With supervision, represents US RA during internal and external audits and Health Authority inspections.

Pre-evaluations and External Partnerships:

• Provides expert US regulatory input and guidance to internal and external pre-evaluation teams (e.g., Due Diligence) and contribute to assessment reports.
• For projects with a CRO or licensing partner, provides and implements US RA strategic and operational perspectives/tasks, as appropriate.

US-Focused Project Support:

• Leads the development of IND/NDA/BLA submission ready documents, including but not limited to briefing packages, Special Designation Requests, etc.
• P…