Director, Global Regulatory Strategy Lead – Eye Health

Boehringer Ingelheim

. Provide strategic regulatory guidance and leadership throughout assigned products’ lifecycles .

Posted 10/26/2026full-timeRemote • United States, GermanySenior💰 $230,400 - $345,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in global regulatory strategies and compliance within the pharmaceutical industry, with a strong ability to analyze complex scientific data and translate regulatory guidance into actionable proposals. Exhibits effective leadership and team management skills while collaborating cross-functionally to drive regulatory excellence throughout product lifecycles.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentRegulatory Science ExpertiseLeadership and Team ManagementRegulatory Submission PlanningRisk Assessment and Mitigation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ProcessesDrug Development KnowledgeScientific Data AnalysisRegulatory Guidelines InterpretationRegulatory Solutions DevelopmentProject-Specific ProposalsRegulatory Intelligence MonitoringLifecycle Management StrategiesContingency PlanningDecision Tree Preparation

Soft Skills

Critical ThinkingEffective CommunicationRelationship BuildingAdaptabilityProactive Problem Solving

Tools & Technologies

MS WordMS ExcelMS Project

Certifications & Qualifications

Master of Drug Regulatory AffairsRAC Certification

Industry Keywords

Pharmaceutical IndustryBiologicsSmall MoleculeRegulatory AffairsHealth Authority MeetingsRegulatory FrameworksDrug LabellingRegulatory MilestonesRegulatory ChallengesTherapeutic Area Knowledge

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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