Hiring: Director/Senior Associate Director, US Product Group Oncology Regulatory Affairs (Hybrid) Company: Boehringer Ingelheim Location: Ridgefield, CT Job Posted Time: 2026-09-13 13:03:53 Employment Type: Hybrid Target Skills & Keywords : Accessibility, Regulatory Compliance About the job Experience: •18 years of age or older Required Skills: •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 •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 Qualifications: •Expertise in multiple therapeutic areas and broad range of regulatory and drug development topics •Bachelors Degree in life sciences, pharmacy, or chemistry from an accredited institution, with extensive drug development experience/knowledge. Doctoral Degree (e.g. PhD) and/or Masters Degree in life sciences, pharmacy, or chemistry, with some drug development experience/knowledge preferred •Five (5) years of experience in regulated pharmaceutical industry (biologics or small-molecule) •Requires a robust and broad range of US regulatory experience and knowledge, from both strategic and operational perspectives •Applies advanced critical thinking with the ability to self-direct workload, including prioritization and timely execution of deliverables in a fast-paced regulatory setting. •Lead team performance under pressure, cultivates a culture of adaptability, and leads strategic responses to regulatory and organizational shifts •Demonstrated advanced interpersonal skills, sound-decision making, and leadership capabilities, fostering strategic partnerships and influencing cross-functional stakeholders across the organization •Navigates complex, matrixed environments with agility, reprioritizing effectively in response to shifting regulatory and business landscapes •Applies seasoned negotiation and conflict resolution skills to align teams and drive regulatory outcomes that support organizational objectives •Drives strategic negotiations and proactively addresses high-impact regulatory issues, balancing risk and opportunity while aligning with organizational priorities and business strategy Compensation: •The position may be eligible for a role specific variable or performance based bonus and or other compensation elements Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!