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.

This role is responsible for new product registration and maintenance of existing product licenses within Taiwan and collaborating with global and Taiwan cross-functional business partners. Engages in trust-based scientific discussion with regulatory officials, while efficiently gaining regulatory go-ahead for top priority products and programs. This role is also accountable to partner with Country Franchise Heads (Vision Care & Surgical) to drive and execute Market Access activities including engaging with relevant government bodies and payers, to negotiate pricing and reimbursement terms, as well as submitting reimbursement dossiers and manage ongoing negotiations.

Major Accountabilities

Regulatory Affairs

• Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for all new products and life cycle management of marketed products in Taiwan, aligned with Global Regulatory and Region and Country business strategies and plans.
• Responsible for establishing and management of regulatory staff in Taiwan and driving performance as measured by expeditious development of plans, regulatory submissions, and approvals in Taiwan.
• Monitor operational progression of pre-marketing authorization activities at the country level through contact with country regulatory agencies or committees, as required.
• Strategic communication with the country's regulatory agencies or committees to expedite new marketing authorization approvals and other operational regulatory interventions.
• Ensures all documents submitted to regulatory agencies are complete, well organized, in regulatory compliance, and presented in a manner that facilitates agency review.
• Responsible for maintaining records of regulatory submissions and communications with the relevant regulatory agencies.
• Work with commercial colleagues to develop promotional strategies and provide regulatory review for promotional materials.
• Develop and maintain excellent working relationships with health authorities; identify regulatory risks for investigational and marketed products and develop strategies to minimize those risks.
• Monitor and provide regulatory intelligence on new medical device legislation, guidance, and policy proposals impacting Alcon’s products or processes. Provide regulatory intelligence on competitive products and companies.
• Accountable for ensuring Alcon is adequately represented in relevant advocacy groups, to ensure the company position is considered as new regulations are proposed by health authorities.

Market Access

• Closely coordinate, support, and align on health policy priorities with Alcon management strategy for surgical products and vision care products franchises.
• Work with the Taiwan commercial team (1) to develop and carry out Alcon’s policy agenda for reimbursement; (2) monitor/track state legislative activity. Prepare and submit reimbursement dossiers and manage ongoing negotiations.
• Develop Alcon relationships with external policy stakeholders such as industry trade associations (e.g., AdvaMed, APACMED), hospital associations, patient advocacy groups (Prevent Blindness), and professional societies (e.g., AAO, AOA, ASCRS)
• Participate in trade association policy working groups and other forums.

Education: A bachelor’s degree in a related field is required.

Languages: Fluent in Mandarin (traditional Mandarin). Excellent level of English as a second language.

Experience:

At least 15 years in Regulatory Affairs, GA & Market Access with significant depth of experience within the medical device industry

At least 10 years of experience leading people and organizations

A track record of successful execution of regulatory/reimbursement submissions and approvals for medical devices/pharmaceutical products

High energy, collaboration, and experience in initiating and leading change

Ability to influence senior stakeholders in a global environment

Why join Alcon?

• Join a global leader with a rich history of innovation and excellence in eye care.
• Be part of a collaborative and supportive team culture that values diversity and inclusion.
• Enjoy a competitive compensation package and opportunities for career advancement.
• Make a meaningful difference in the lives of patients worldwide by contributing to cutting-edge advancements in eye health.

If you're ready to take the next step in your career and lead a dynamic team towards success, we want to hear from you! Apply now and join us in shaping the future of eye care at Alcon.

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