Taiwan Job Openings
Alcon
Senior Manager, Regulatory Affairs
FULL TIME
September 18, 2024
- 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.
- 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., Adva Med, 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.
- 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.
ATTENTION: Current Alcon Employee/Contingent Worker
New Job Alerts
BI Taiwan Ltd
醫藥業務專員 (中區) - Emerging Sector / Medical Sales Specialist, Central - Emerging Sector
FULL TIME
September 23, 2024
View Job DescriptionKeller Executive Search
Director of Asia Operations - Manufacturing, sports consumer technology, Taichun
September 23, 2024
View Job DescriptionSHL Medical AG
PDCP - Manufacturing Technology Development Engineer
FULL TIME
September 23, 2024
View Job DescriptionBI Taiwan Ltd
醫藥業務專員 (北區) - CRM / Medical Sales Specialist, North - CRM
FULL TIME
September 23, 2024
View Job DescriptionLooking for similar job?
Lightsource BP
Senior Business Development Manager, Taiwan
FULL TIME
August 30, 2024
View Job DescriptionRebound Singapore Pte Ltd (Taiwan Branch)
Senior Account Manager - Computer Products - Taiwan
FULL TIME
August 28, 2024
View Job DescriptionAmazon Data Services Taiwan Limited
Data Center Operation Technician (Senior IT Specialist), TPE - DCO
August 27, 2024
View Job DescriptionNew Job Alerts
BI Taiwan Ltd
醫藥業務專員 (中區) - Emerging Sector / Medical Sales Specialist, Central - Emerging Sector
FULL TIME
September 23, 2024
View Job DescriptionKeller Executive Search
Director of Asia Operations - Manufacturing, sports consumer technology, Taichun
September 23, 2024
View Job DescriptionSHL Medical AG
PDCP - Manufacturing Technology Development Engineer
FULL TIME
September 23, 2024
View Job DescriptionBI Taiwan Ltd
醫藥業務專員 (北區) - CRM / Medical Sales Specialist, North - CRM
FULL TIME
September 23, 2024
View Job Description