Sr. Associate, Regulatory Affairs Strategy

Alcon MX; Fort Worth (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health

Life Insurance

Retirement Plan

Flexible time off

PTO for hourly associates

Job summary

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

You will partner with cross-functional teams to ensure timely, compliant market access across global regions. Applicants should have a Bachelor’s degree and at least 2 years of relevant experience, with strong English communication and ability to work onsite.

Qualifications

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand, and communicate in English
• 2 Years of Relevant Experience
• Work hours: Monday – Friday, 8:00 AM CST – 5:00 PM CST
• Location: Onsite (Candidates may be considered to sit at other approved Alcon locations)
• Travel Requirements: Up to 10%
• Sponsorship & Relocation: Not Available

Responsibilities

• Lead regulatory projects, ensuring milestones through planning and stakeholder alignment
• Develop and execute global regulatory strategies for registrations, submissions, renewals, supplements, and lifecycle management
• Serve as primary regulatory representative, guiding authority interactions and negotiations for approvals
• Provide strategic regulatory input for new product development, changes, and post-approval activities
• Ensure timely approvals and maintenance of regulatory approvals for marketed products worldwide
• Review and ensure compliance of commercial, promotional, and labeling materials with regulations
• Interpret global regulatory requirements and translate into practical business solutions
• Lead post-market regulatory activities including inspections, audits, inquiries, reporting, and regulatory records
• Monitor emerging regulatory trends and provide regulatory intelligence to stakeholders
• Ensure compliance with GxP, procedures, and training expectations
• Drive continuous improvement of regulatory processes and operations

Skills

Regulatory strategy

Regulatory writing

Cross-functional influence

Regulatory compliance

Project management

Education

Bachelor's degree or equivalent

Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? This role is part of Alcon’s Quality & Regulatory Affairs function, a team dedicated to ensuring our products meet global regulatory requirements and the highest standards of quality, safety, and compliance as we help people see brilliantly. The Sr. Associate, Regulatory Affairs Strategy (Professional Path) is responsible for leading regulatory strategy, compliance, and lifecycle management activities for Alcon’s Dry Eye Ocular Health and Contact Lens Care portfolio. This individual will play a critical role in driving regulatory excellence, supporting business objectives, and enabling timely, compliant access to innovative products across global markets while upholding Alcon’s commitment to quality, compliance, and patient safety.

Specifics Include:

• Lead and manage multiple regulatory projects, ensuring successful execution of key milestones through effective planning, collaboration, and stakeholder alignment
• Develop and execute global regulatory strategies for product registrations, submissions, renewals, supplements, and lifecycle management activities
• Serve as the primary regulatory representative, providing guidance on regulatory authority interactions and supporting negotiations to facilitate product approvals
• Provide strategic regulatory input for new product development, product changes, process improvements, and post-approval activities
• Ensure timely approvals and ongoing maintenance of regulatory approvals for marketed products worldwide
• Review and ensure compliance of commercial, promotional, and labeling materials in accordance with applicable regulations and company standards
• Interpret and apply global regulatory requirements, translating complex regulations into practical business solutions
• Lead post-market regulatory activities, including regulatory inspections, audits, inquiries, reporting requirements, and maintenance of regulatory records
• Monitor and assess emerging regulatory trends and global requirements, providing regulatory intelligence and actionable recommendations to stakeholders
• Ensure compliance with applicable Good Practice (GxP) regulations, internal procedures, documentation requirements, and training expectations
• Drive continuous improvement initiatives that enhance regulatory processes, compliance effectiveness, and operational excellence

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
• The ability to fluently read, write, understand, and communicate in English
• 2 Years of Relevant Experience
• Work hours: Monday – Friday, 8:00 AM CST – 5:00 PM CST
• Location: Onsite (Candidates may be considered to sit at other approved Alcon locations)
• Travel Requirements: Up to 10%
• Sponsorship & Relocation: Not Available

PREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:

• Strong ability to develop and execute global regulatory strategies for complex medical devices
• Proven ability to influence cross-functional stakeholders and senior leadership
• Excellent communication, negotiation, and regulatory writing skills
• Ability to manage multiple priorities in a fast-paced, matrixed environment
• Strong analytical thinking and problem-solving capabilities
• Demonstrated commitment to quality, compliance, and patient safety

HOW TO THRIVE AT ALCON:

Collaborate with teammates to share standard processes and learnings as work evolves!

See your career like never before with focused growth and development opportunities!

Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

Benefits:

• health
• life
• retirement
• flexible time off for exempt associates
• PTO for hourly associates
• and much more

ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.

At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.