Director, Global Regulatory Strategy Lead – Eye Health

Job not on LinkedIn

🔥 6 minutes ago

🌐 United States, Germany – Remote

🇺🇸 United States – Remote 🇩🇪 Germany – Remote

💵 $230.4k - $345.6k / year

⏰ Full Time

🟠 Senior

🧐 Strategy

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Boehringer Ingelheim

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Boehringer Ingelheim is a global, research-driven, family-owned pharmaceutical company headquartered in Germany that discovers, develops, manufactures, and markets prescription medicines, biopharmaceuticals, vaccines, and animal health products. The company focuses on therapeutic areas including respiratory, cardiovascular, metabolic, oncology, immunology, and zoonotic diseases, and invests heavily in R&D and biotechnology to advance drug discovery and development. It operates worldwide across both human pharmaceuticals and animal health markets, partnering with academic institutions and biotech firms to translate scientific research into therapies.

📋 Description

• Provide strategic regulatory guidance and leadership throughout assigned products’ lifecycles • Develop and own global regulatory strategies for assigned assets • Lead the Regulatory Excellence Team and represent Global Regulatory Affairs on the Evidence Team • Assess regulatory risks, options, opportunities, and potential challenges • Propose innovative regulatory solutions to accelerate development and approval • Align regulatory strategies with business objectives, country prioritization, and regional requirements • Collaborate cross-functionally with Evidence, Asset, Regulatory Project Manager, and other stakeholders • Shape early target label profiles and provide input to the Company Core Datasheet • Support regional and local drug-labelling discussions • Oversee planning and execution of regulatory submissions • Support submission rollout for Rest of World countries • Oversee lifecycle-management strategies for marketed products, including variations, supplements, and line extensions • Monitor worldwide regulations, guidelines, trends, and regulatory intelligence • Communicate regulatory changes and recommend strategy adaptations • Develop contingency plans and provide risk/benefit analyses • Analyze competitive landscapes and identify innovative regulatory pathways • Contribute to health-authority meetings, briefing documents, policy development, and regulatory frameworks • Maintain oversight of local regulatory-affairs activities • Mentor team members and contribute to training, workshops, and knowledge-sharing • Provide regulatory input throughout product development and prepare teams for regulatory meetings, advisory committees, and inspections • Provide regular updates on regulatory milestones and project timelines

🎯 Requirements

• Bachelor’s degree in pharmacy, life sciences or chemistry required • Seven (7) years’ experience in regulated pharmaceutical industry (biologics or small molecule) required • In-depth knowledge of regulatory science and global regulatory requirements, guidelines, developments, and standards • Thorough understanding of regulatory processes and core drug development areas • Ability to analyze and interpret complex scientific data and regulatory guidelines • Ability to translate regulatory guidance into project-specific proposals and compliant regulatory solutions • Commercial awareness and understanding of business environment, therapeutic area, and development projects • Ability to work autonomously in a highly efficient manner • Critical thinking and ability to self-direct workload and meet tight timelines • Strategic mindset and top-down perspective • Adaptability, learning agility, and flexibility in changing regulatory environments • Proactive approach and ownership of regulatory challenges and opportunities • Effective leadership and team management skills • Strong interpersonal, relationship-building, and conflict-management skills • Excellent verbal and written communication skills • Ability to summarize complex scientific and regulatory questions into clear slides and text • Ability to prepare scenarios and decision trees • Strong organizational and time management skills • Fluency with MS Word, Excel, Project, and similar computer software • 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 • Master’s or doctoral degree, specialized pharmacist qualification, Master of Drug Regulatory Affairs, and RAC certification preferred or additional qualifications

🏖️ Benefits

• Competitive compensation and benefit programs • Medical coverage • Dental coverage • Vision coverage • Retirement savings opportunities • Paid time off • Paid holidays • Disability insurance • Life insurance benefits • Other company-sponsored programs • Role-specific discretionary bonus eligibility • Relocation compensation may be available • Work-life balance support • Mobility and networking opportunities • Professional development courses, conferences, workshops, and webinars