Director, Global Regulatory Strategy Lead – Eye Health

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Deliver strategic regulatory guidance and leadership across the lifecycles of assigned products.

• Create and manage global regulatory strategies for designated assets.

• Lead the Regulatory Excellence Team and act as the representative for Global Regulatory Affairs on the Evidence Team.

• Evaluate regulatory risks, options, opportunities, and potential obstacles.

• Suggest innovative regulatory solutions to expedite development and approval processes.

• Align regulatory strategies with business objectives, country prioritization, and regional requirements.

• Collaborate across functions with Evidence, Asset, Regulatory Project Manager, and other stakeholders.

• Influence early target label profiles and offer input for the Company Core Datasheet.

• Assist in regional and local drug-labeling discussions.

• Oversee the planning and execution of regulatory submissions.

• Facilitate submission rollout for countries in the Rest of World segment.

• Supervise lifecycle management strategies for marketed products, including variations, supplements, and line extensions.

• Keep track of global regulations, guidelines, trends, and regulatory intelligence.

• Communicate regulatory changes and propose strategic adaptations.

• Develop contingency plans and conduct risk/benefit analyses.

• Analyze competitive landscapes and discover 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 participate in training, workshops, and knowledge-sharing initiatives.

• Offer regulatory input throughout product development and prepare teams for regulatory meetings, advisory committees, and inspections.

• Provide regular updates regarding regulatory milestones and project timelines.

⛳️ Requirements

• Bachelor’s degree in pharmacy, life sciences, or chemistry is required.

• A minimum of seven (7) years of experience in the regulated pharmaceutical industry (biologics or small molecule) is required.

• Comprehensive knowledge of regulatory science and global regulatory requirements, guidelines, developments, and standards.

• Strong understanding of regulatory processes and core areas of drug development.

• Ability to analyze and interpret complex scientific data and regulatory guidelines.

• Capability to translate regulatory guidance into project-specific proposals and compliant regulatory solutions.

• Commercial awareness and understanding of the business environment, therapeutic area, and development projects.

• Capacity to work independently in a highly efficient manner.

• Critical thinking skills and the ability to self-manage workload while meeting tight deadlines.

• Strategic mindset with a top-down perspective.

• Adaptability, learning agility, and flexibility in evolving regulatory environments.

• Proactive approach with a sense of ownership regarding regulatory challenges and opportunities.

• Strong leadership and team management capabilities.

• Excellent interpersonal, relationship-building, and conflict-management skills.

• Superior verbal and written communication skills.

• Aptitude for summarizing complex scientific and regulatory questions into clear slides and text.

• Proficiency in preparing scenarios and decision trees.

• Strong organizational and time management abilities.

• Proficient in MS Word, Excel, Project, and similar software.

• Must be legally authorized to work in the United States without any restrictions.

• Must be willing to undergo a drug test and post-offer physical if required.

• Must be at least 18 years of age.

• A Master’s or doctoral degree, specialized pharmacist qualification, Master of Drug Regulatory Affairs, and RAC certification are preferred or other additional qualifications.

🏝️ Benefits

• Competitive compensation and benefits packages.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• Retirement savings opportunities.

• Paid time off.

• Paid holidays.

• Disability insurance.

• Life insurance benefits.

• Additional company-sponsored programs.

• Eligibility for role-specific discretionary bonuses.

• Potential relocation compensation.

• Support for work-life balance.

• Opportunities for mobility and networking.

• Access to professional development courses, conferences, workshops, and webinars.