Director, Regulatory Affairs Strategy
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Job Location:
Lake Forest, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
At Alcon we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly champion progress and act with speed as the global leader in eye care. Here youll be recognized for your commitment and contributions and see your career like never before. Together we go above and beyond to make an impact in the lives of our patients and customers.
We foster an inclusive culture and are looking for diverse talented people to join Alcon. As a Director Regulatory Affairs Strategy (Management Path) supporting Alcons Quality & Regulatory Affairs organization this onsite role based at our Lake Forest California main campus is responsible for developing and executing regulatory strategies to obtain and maintain product approvals across Alcons franchise portfolios. This position plays a critical role in ensuring products and processes meet global regional and local regulatory requirements.
Primary responsibilities include providing strategic regulatory leadership across the product lifecycle preparing and overseeing highquality regulatory submissions and serving as the primary liaison with global health authorities to support timely product approvals. Additional responsibilities include leading and developing regulatory teams collaborating crossfunctionally with R&D Quality Manufacturing and Commercial partners and driving lifecycle management strategies to ensure ongoing compliance and business continuity.
The Director will be responsible for the Consoles sub-team within the Consoles Consumables & Accessories and Digital Health (CCD) organization of the Instrumentation GRA franchise.
This role is part of Alcons Quality & Regulatory Affairs function ensuring products meet the highest standards of quality safety and regulatory compliance. All associates are required to adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) maintaining accurate and complete documentation completing required training and supporting a culture of continuous improvement and regulatory excellence.
In this role a typical day will include:
- Lead a department within the Regulatory Affairs Strategy team developing and implementing strategies for success and alignment with company goals
- Direct the development and submission of product/process registrations progress reports supplements amendments and periodic experience reports
- Provide strategic product direction to teams and negotiate evidence requirements with regulatory agencies
- Ensure rapid and timely approval of products and their continued approval
- Serve as the regulatory representative to marketing research project teams and government regulatory agencies
- Advise development and commercial teams on new product development safety efficacy manufacturing changes product line extensions labeling and regulations
- Oversee regulatory affairs activities including product submissions renewals and updates ensuring timely submission and approvals
- Oversee promotional material approval ensuring ethical conduct and compliance with laws and regulations
- Provide regulatory strategies for new product introductions and product changes maintaining regulatory compliance
- Support products in the medical device family ensuring adherence to relevant regulations
- Collect and analyze regulations/standards to ensure product compliance and engage in activities of industry associations like Advanced Medical Technology Association (AdvaMed)
- Support post-market inspection and explain approved information to customers maintaining approval information in internal systems
- Focus on talent development to enhance capabilities
- Lead globally aligned regulatory strategies across development portfolios marketed products and line extensions
- Manage post-approval commitments and lifecycle management
- Guide teams on product development safety efficacy and compliance while interacting with health authorities
- Coordinate regulatory activities for timely approvals and compliance
- Lead and supervise regulatory liaisons ensuring synergy across projects and driving competitive advantage through strategic decision-making
Minimum Qualifications:
- Bachelors Degree or Equivalent years of directly related experience (or high school 18 yrs.; Assoc.14 yrs.; M.S.7 yrs.; PhD6 yrs.)
- The ability to fluently read write understand and communicate in English.
- Sponsorship Availability: No
- Relocation Assistance Availability: No
HOW TO THRIVE AT ALCON:
- Benefit from working in a highly collaborative environment.
- Join Alcons mission to provide top-tier innovative products to enhance sight enhance lives and grow your career.
- Alcon provides robust benefits package including health life retirement flexible time off and much more!
Preferred Qualifications:
- 6 Years of Demonstrated Leadership
- 10 Years of Relevant Experience
Alcon Careers
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Total Rewards
Alcons Total Rewards programs are designed to align to incentives with business goals encourage the right values and behaviors and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay which includes short-term incentives and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance supports savings for retirement promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcons Corporate Social Responsibility including our Total Rewards click here
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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 and let us know the nature of your request and your contact information.
Required Experience:
Director
Key Skills
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
