Global Regulatory Strategy Lead — Medical Devices

Alcon; Fort Worth (TX); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health benefits

Life insurance

Retirement plan

Flexible time off

Job summary

Alcon is seeking a Sr. Associate, Regulatory Affairs Strategy (Professional Path) to lead regulatory strategy, compliance, and lifecycle management for Dry Eye Ocular Health and Contact Lens Care products.

You’ll drive global submissions, interact with authorities, and shape lifecycle plans while ensuring patient safety and quality. The role requires strong regulatory writing, cross‑functional influence, and the ability to manage multiple priorities in a fast-paced environment.

Qualifications

• Bachelor's degree or equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; MS +0 yrs).
• Fluently read, write, understand, and communicate in English.
• At least 2 years of relevant regulatory experience.

Responsibilities

• Lead and manage multiple regulatory projects with milestones and stakeholder alignment.
• Develop and execute global regulatory strategies for registrations, submissions, renewals, and lifecycle management.
• Serve as primary regulatory representative guiding authority interactions and negotiations.
• Provide regulatory input for new product development, changes, and post‑approval activities.
• Ensure timely regulatory approvals and maintenance of global registrations.
• Review compliance of marketing, labeling, and promotional materials.
• Translate complex regulations into practical business solutions.
• Drive post-market activities including inspections, audits, inquiries, and recordkeeping.
• Monitor regulatory trends and provide actionable intelligence to stakeholders.
• Ensure GxP compliance and drive continuous improvement in regulatory processes.

Skills

Global regulatory strategy

Regulatory writing

Stakeholder influence

Project management

English proficiency

Regulatory compliance

Analytical thinking

Education

Bachelor's Degree or equivalent

Job description

Alcon is seeking a Sr. Associate, Regulatory Affairs Strategy (Professional Path) to lead regulatory strategy, compliance, and lifecycle management for Dry Eye Ocular Health and Contact Lens Care products.

You’ll drive global submissions, interact with authorities, and shape lifecycle plans while ensuring patient safety and quality. The role requires strong regulatory writing, cross‑functional influence, and the ability to manage multiple priorities in a fast-paced environment.