Senior Regulatory Operations Leader – Global Submissions

Alcon; Fort Worth (TX); On-site; USD 152,000 - 197,000; Full time

Job summary

Alcon is seeking a Sr. Manager, Regulatory Operations to direct global submissions and optimize regulatory strategies.

You will lead cross-functional teams across the US, EU, and Canada, ensuring timely approvals and high-quality support for medical devices and pharmaceuticals. Ideal candidates will have extensive regulatory experience, strong leadership, and a proven ability to manage complex dossiers while adhering to GxP, SOPs, and continuous improvement initiatives in a fast-paced

Qualifications

• Bachelor’s degree or equivalent years of directly related experience.
• Fluent reading, writing, understanding and communicating in English.
• 7+ years of relevant regulatory experience.
• 5+ years of demonstrated leadership.

Responsibilities

• Oversee multiple regulatory operations projects to meet goals with effective management and oversight.
• Lead teams for dossier preparation, submission management, licensing and labeling with timely submissions.
• Make key decisions impacting project performance and success.
• Apply project management, problem-solving, communication and leadership.
• Adhere to GxP regulations, SOPs, documentation and quality control.
• Commit to continuous improvement and regulatory compliance.

Skills

Regulatory submissions lifecycle

GxP compliance

Project leadership

Regulatory strategy

Education

Bachelor's degree in a related field

Tools

FDA eSTAR

Health Canada REP

CDRH CECATS

EU Notified Body portals

Job description

Alcon is seeking a Sr. Manager, Regulatory Operations to direct global submissions and optimize regulatory strategies.

You will lead cross-functional teams across the US, EU, and Canada, ensuring timely approvals and high-quality support for medical devices and pharmaceuticals. Ideal candidates will have extensive regulatory experience, strong leadership, and a proven ability to manage complex dossiers while adhering to GxP, SOPs, and continuous improvement initiatives in a fast-paced