Director, Scientific Expert CMC

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. We foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect our high regard for our employees.

The Director, Scientific Expert CMC is responsible for providing new product and marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls (CMC) function for pharmaceutical products in line with Company policies, business strategies and priorities, in close collaboration with Quality, R&D and Operations/Manufacturing. The Director provides subject matter expertise in CMC-related areas and may serve as a Global Regulatory Project Lead within the project core team or as a functional expert on complex technical topics.

• Spearheads the preparation, critical review, and timely submission of regulatory dossiers to global Health Authorities, ensuring alignment with evolving international standards and regulatory expectations
• Provides strategic technical knowledge across cross-functional teams, guiding the development and execution of robust regulatory and quality strategies in CMC
• Demonstrates a proven track record of regulatory success, ensuring product development objectives are achieved efficiently and compliantly
• Defines, plans, and oversees the development of high-quality CMC regulatory submissions to secure timely approvals
• Delivers expert, topic-specific regulatory guidance tailored to international requirements, aligning with global business strategies
• Proactively assesses and resolves complex CMC-related risks, managing end-to-end processes to ensure regulatory compliance and operational efficiency
• Provides expert guidance, direction, and training to cross-functional teams on global regulatory requirements, timelines, and Authority expectations
• Interprets and applies regulatory standards to uphold excellence in R&D and Manufacturing, serving as a regulatory resource
• Collaborates with R&D, Operations, Quality Assurance, and Legal teams to ensure regulatory alignment across internal manufacturing and external partnerships with CMOs
• Serves as a trusted SME in product development, contributing to cross-functional project teams with high-level regulatory consultation
• Evaluates potential licensing opportunities with comprehensive global CMC regulatory assessments
• Guides regulatory function and interfaces with internal departments and external manufacturing sites to ensure compliance
• Represents regulatory affairs during manufacturing site inspections, guiding Operations and Quality teams for inspection readiness
• Develops professional relationships with regulatory agency contacts and industry groups
• Acts as primary liaison to Health Authorities and BI Regulatory Teams for foreign registrations
• Builds collaborative relationships with key functional stakeholders within Boehringer Ingelheim and CMOs
• Monitors regulatory trends and informs the organization of new guidelines and agency initiatives
• Leads departmental process improvements and special projects as assigned
• Promotes ownership, agility, accountability, and an entrepreneurial mindset
• Aligns with global, regional, and local regulatory objectives and executes as planned

• Advanced degree in Life Sciences and/or related field
• Proven leadership and project management skills
• 15+ years of industry experience with exposure to global Regulatory Authorities
• 10+ years of direct CMC experience in a pharmaceutical setting
• Fluent in English
• Regulatory certification or degree preferred
• Deep expertise in chemistry, biochemistry, molecular biology, and regulatory CMC strategy
• Ability to manage complex, multidisciplinary workloads independently
• Strong command of pharmaceutical sciences across small molecule and biological drug development, analytical chemistry, and formulation science
• Ability to influence cross-functional teams without direct authority
• Attention to detail with a strategic, systems-level perspective
• Accountability, integrity, and…