Sr. Associate I, Regulatory Affairs Strategy

Sr. Associate I, Regulatory Affairs Strategy

POSITION OVERVIEW:

The Regulatory Affairs Specialist is responsible for supporting the RA function in the Product Lifecycle Management and maintenance to support business needs.

KEY RESPONSIBILITIES

• Regulatory Affairs

• Drive Product Registration, re-registration, change notification and related license applications & maintenance.

• Drive product lifecycle management activities (labeling changes, new regulations assessment and preparation, CPDS, promotional material reviews)

• Manage administrative and coordination activities e.g., project & metric management, archival of licenses/ permit, invoice & payment tracking and follow up, operational support etc.

• Other Regulatory Activities

• Regulatory support to local teams

• Newcomer onboardings

• Support other duties as and when assigned

• Key Performance Indicators

• Ensure timely new registration/re-registration of Alcon products in assigned markets

• Ensure successful variation and change notification of Alcon products in assigned markets

• Ensure successful execution of assigned lifecycle management activities

• Review of Promotional Materials for compliance with regulations in assigned markets

• Number and scope of process improvement initiatives completed that significantly drive productivity of the RA organization

WHAT YOU’LL BRING TO ALCON:

Education

• Degree in Engineering or Pharmacy or Science or related scientific discipline or equivalent

Languages:

• Fluent in English is required both oral and written
• Fluent in any other additional markets within APAC (Korean, Japanese, Thai) languages both oral and written is a plus

Key Competencies/Behaviours:

• Results Driven
• Leadership
• Customer / Quality Focus
• Empowerment / Accountability
• Mutual Respect / Trust / Loyalty

Experience

• Ideally 1-2 year of experience as an associate in regulatory affairs dealing with a wide variety of registration projects and issues.
• Fresh graduates with relevant academic background will be considered
• Good interpersonal and communication skills and ability to manage effectively in an international environment
• Ability to work independently, under pressure, meeting tight deadlines, demonstrating high level of initiative and flexibility
• Strong problem-solving skills
• Integrity, responsive, high commitment
• Computer literate and knowledge of Excel and PDF

HOW YOU CAN THRIVE AT ALCON:

• Opportunity to work with a leading global medical device company

• Collaborate with a diverse and talented team in a supportive work environment

• Competitive compensation package and comprehensive benefits

• Continuous learning and development opportunities

• Alcon Careers

• See your impact at alcon.com/careers

• 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.

• 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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• About Us

• At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide.

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• 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.

• Find Jobs for Employees

• Find Jobs for Contingent Worker

• Read More

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