Senior Director, Regulatory Affairs Strategy & BD&L

Alcon; Fort Worth (TX); On-site; USD 218,000 - 283,000; Full time

Benefits offered by this job

Relocation assistance

Onsite Fort Worth workplace

Job summary

Alcon is seeking a Sr. Director, Regulatory Affairs Strategy (Management Path) to lead global regulatory plans and ensure timely product approvals. You will guide development teams on safety, efficacy, and compliance, while coordinating with plants and regulatory agencies to drive submissions and approvals.

You will manage multiple departments, mentor leaders, and align regulatory strategies with corporate goals, with minimal travel and onsite Fort Worth responsibilities.

Qualifications

• Bachelor's degree required.
• Fluent in reading, writing, and speaking English.
• 12+ years of relevant regulatory experience.
• 8+ years of leadership experience.

Responsibilities

• Lead global regulatory plans and product strategies for assigned products.
• Direct regulatory submissions, renewals, and reporting.
• Provide strategic regulatory guidance to development and commercial teams.
• Ensure ongoing compliance with GxP and SOPs across products.

Skills

Leadership

Regulatory strategy

GxP compliance

SOP adherence

English fluency

Education

Bachelor's Degree

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 that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Director, Regulatory Affairs Strategy (Management Path) is primarily responsible for developing and driving strategies for Quality and Regulatory oversight. You will lead product registration, provide strategic guidance, and negotiate with regulatory agencies to ensure timely product approvals. You will also support business development activities and serve as a regulatory liaison, advising on product development, safety, and compliance, while leading a department to align strategies with company goals. Specifics Include:

• Lead multiple departments or a large division within the Regulatory Affairs team, providing strategic leadership and ensuring compliance with regulatory requirements
• Leads preparation of global regulatory plans and product strategies for assigned products.
• Manage and provide regulatory support on business development and licensing activities that aligns with corporate strategy.
• Manage and participate in conducting regulatory due diligence activities.
• Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports
• Provide strategic product direction to teams, interact and negotiate evidence requirements with regulatory agencies, and ensure rapid and timely approval of products and their continued approval
• Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and appropriate regulations and interpretations
• Oversee the execution and coordination of various regulatory affairs activities, including product submissions, renewals, and updates by coordinating between plants, agents, and continuously communicating with all parties involved to ensure timely submission and approvals
• Provide regulatory strategies and risk assessments/mitigation for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
• Support products in either the medical device and/or pharmaceutical family of products, ensuring adherence to all relevant regulations
• Lead strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills to impact multiple departments to ensure synergy across projects, driving competitive advantage through strategic decision-making, and the overall business outcomes
• Focus on talent development to enhance capabilities.
• Ensure all associates adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
• Contribute to the overall compliance of the organization and commit to continuous improvement in operations
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

What You'll Bring to Alcon

• Bachelor's Degree
• The ability to fluently read, write, understand and communicate in English
• 12 Years of Relevant Experience
• 8 Years of Demonstrated Leadership
• Travel: Minimal
• Work Location: Onsite - Fort Worth, TX(This role may be based at other Alcon locations, subject to business needs)
• Relocation Assistance: Yes
• Sponsorship: None

How you can thrive at Alcon:

• Work together with colleagues to share standard methodologies and discoveries as work progresses.
• Discover your career in a fresh way through specific growth and development possibilities.
• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

Alcon Careers

ATTENTION: Current Alcon Employee/Contingent Worker

Compensation and Benefits

Alcon's Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver longterm value. Our compensation approach includes a combination of fixed and variable pay, with shortterm and longterm incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and wellbeing, provide financial security, and support retirement planning.

The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.

Pay Range

218,450.00 - 282,700.00

Pay Frequency

Annual

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, 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.