Senior RA Specialist

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, you'll 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. We are looking to hire a Senior Regulatory Affairs Specialist to join our Global Regulatory Affairs Surgical team in Lake Forest, CA. The ideal candidate will be responsible for interpreting regulations as they apply to products, financial processes, and other processes, practices and procedures as well as investigating and resolving compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.

In this role, a typical day will include:

• Implementation of policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and that regulatory reporting requirements are met.

• May develop and implement programs designed to increase employee awareness and knowledge of compliance policies.

• May audit or evaluate current policies, procedures, and documentation for compliance with government laws and regulations.

• May include compliance review and approval of promotional materials.

• May provide input to marketing and/or research and development on new product opportunities as a result of changes in the regulatory environment.

• May develop and direct compliance training and monitoring programs.

• Works in close collaboration with internal stakeholders and supports multiple projects.

• Provides support as needed for non-project related "regulatory excellence" activities.

• Ensures compliance with global regulatory requirements and adherence to internal policies and processes.

• Responds to regulatory requests from across the organization in a timely manner.

• Provides high quality regulatory support for assigned products/projects.

• Partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy to achieve business objectives.

• Develops training programs for internal stakeholders, as needed.

• Develops documents that are clear, concise, and complete to facilitate reviews/approvals.

• Demonstrated ability to coordinate and work effectively with multiple stakeholders.

• Ensures timely, clear communications to internal stakeholders on project status and issues.

• Serves as role model and embraces corporate Values and Behaviors.

• Demonstrated good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.

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: 40 hours

• Travel Requirements: 0%

PREFERRED QUALIFICATIONS:

• Meets individual goals as defined in the annual objectives.

• Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.

• Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.

• Strong writing skills in the form of high-quality regulatory submission documents.

• Committed to drive efficiency while maintaining quality.

• Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.

HOW YOU CAN THRIVE AT ALCON:

• 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!

• Alcon provides robust benefits package including health, life, retirement, flexible time off and much more.

• Readily takes action in challenging situations; identifies and seizes new opportunities; displays a can-do attitude at all times.

• Gains insight into customer needs and executes beyond customer expectations; builds and delivers solutions that meet/exceed customer expectations; establishes and maintains effective customer relationships. This is true for BOTH internal and external customers.

• Planning and prioritizing work to meet commitments aligned with program goals; uses milestones to diligently track and manage progress; develops implementation plans to appropriately allocate meeting resources

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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Total Rewards

Alcon's 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 Alcon's 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.