Director, Scientific Expert CMC

Description

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.

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, Scientific Expert CMC provides subject matter expertise in functional areas related to, and driven by, Chemistry, manufacturing and or control strategies for chemical, biotech and biological products. The incumbent may serve as a Global Regulatory Project Lead within the project core team or serve as a functional expert on complex technical topics.

Duties & Responsibilities

• 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, leveraging deep expertise in Chemistry, Manufacturing, and Controls (CMC) to guide the development and execution of robust regulatory and quality strategies.
• Demonstrates a proven track record of regulatory success, underpinned by extensive experience and a high level of technical competency, ensuring that product development objectives are achieved efficiently, compliantly, and in alignment with corporate goals.
• Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from global Health Authorities.
• Delivers expert, topic-specific regulatory guidance tailored to international requirements, ensuring alignment with global business strategies and collaborative objectives across strategic partnerships.
• Proactively assesses and resolves complex CMC-related risks, recommending strategic actions and managing end-to-end processes to ensure regulatory compliance and operational efficiency.
• Provides expert guidance, direction, and training to cross-functional teams based on a deep and current understanding of global regulatory requirements, submission timelines, and Health Authority expectations.
• Interprets and applies regulatory standards to uphold excellence in R&D and Manufacturing, serving as a key resource for regulatory insight and compliance strategy.
• Collaborates closely with R&D, Operations, Quality Assurance, and Legal teams to ensure consistent quality and regulatory alignment across internal manufacturing and external partnerships with Contract Manufacturing Organizations (CMOs).
• Serves as a trusted subject matter expert (SME) in product development, actively contributing to cross-functional project teams and providing high-level regulatory consultation throughout the product lifecycle.
• Delivers expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development initiatives.
• Provides authoritative guidance across the regulatory function, interfacing with internal departments and external manufacturing sites to ensure full compliance with regulatory standards governing BIAH products and processes.
• Represents regulatory affairs as a key leader during manufacturing site inspections, offering critical insights and direction to Operations and Quality teams to ensure alignment with Health Authority expectations and inspection readiness.
• Works with and develop professional relationships with regulatory agency contacts and regulatory industry groups; discuss and negotiate issues with regulatory agencies.
• Acts as primary liaison to Health Authorities and BI Regulatory Teams for foreign registrations.
• Establishes collaborative and productive relationships with key functional players within Boehringer Ingelheim and CMOs.
• Understands/monitors regulatory trends and work with team to influence legislation/guidance and to inform organization of new guidelines, directives, and agency initiatives.
• Acts as RA Subject Matter Expert regarding legislation a