Boehringer Ingelheim
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.
Role 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.
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, 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
Requirements
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 data-driven decision making
Mentorship and a culture of continuous learning
Intrapreneurial spirit to translate concepts into strategies and outcomes
Agility in turning data into insights to accelerate timelines
Customer-focused approach to engagements
Willingness to travel globally up to 20%
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
Company & Why Boehringer Ingelheim With us, you can develop your own path in a company that values differences as strengths and aims to transform lives. We invest in programs and groups that support health and wellbeing and drive global accessibility to healthcare.
Want to learn more? Visit https://www.boehringer-ingelheim.com
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Pharmaceutical Manufacturing
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Role 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.
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, 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
Requirements
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 data-driven decision making
Mentorship and a culture of continuous learning
Intrapreneurial spirit to translate concepts into strategies and outcomes
Agility in turning data into insights to accelerate timelines
Customer-focused approach to engagements
Willingness to travel globally up to 20%
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
Company & Why Boehringer Ingelheim With us, you can develop your own path in a company that values differences as strengths and aims to transform lives. We invest in programs and groups that support health and wellbeing and drive global accessibility to healthcare.
Want to learn more? Visit https://www.boehringer-ingelheim.com
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Research, Analyst, and Information Technology
Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr