Onsite Regulatory Submissions Leader - Med Device

Alcon; Lake Forest (CA); On-site; USD 170,000 - 210,000; Full time

Job summary

Alcon, a leader in eye care, seeks a Sr. Manager of Regulatory Operations to direct product and process submissions and align regulatory strategies worldwide.

This onsite role supports Fort Worth, TX and Lake Forest, CA, leading teams across dossier preparation, publishing, and labeling to secure timely approvals. The ideal candidate brings deep regulatory expertise across the U.S., EU, and Canada, drives process improvements, mentors teams, and optimizes submission timelines within GxP

Qualifications

• Deep regulatory expertise across US, EU and Canada.
• Experience leading regulatory operations teams.
• Proven track record of on-time approvals within global programs.

Responsibilities

• Direct product and process submissions worldwide.
• Lead dossier preparation, publishing and labeling.
• Align regulatory strategies with global teams and timelines.
• Mentor regulatory teams to optimize submission timelines within GxP.

Skills

Regulatory submissions

Dossier management

Global regulatory strategy

GxP compliance

Team leadership

Publishing

Labeling

Tools

eCTD publishing software

Regulatory Information Management (RIM)

Job description

Alcon, a leader in eye care, seeks a Sr. Manager of Regulatory Operations to direct product and process submissions and align regulatory strategies worldwide.

This onsite role supports Fort Worth, TX and Lake Forest, CA, leading teams across dossier preparation, publishing, and labeling to secure timely approvals. The ideal candidate brings deep regulatory expertise across the U.S., EU, and Canada, drives process improvements, mentors teams, and optimizes submission timelines within GxP