Sr. Associate I, Regulatory Affairs Strategy
Alcon
Selangor, Malaysia
Full-Time
$3
OfficeAssociate
At Alcon, we are inspired by the meaningful work we do to help people see brilliantly. As the global leader in eye care, we boldly innovate, champion progress, and act with speed. We recognize and celebrate the contributions of our people, offering career opportunities that empower growth and fulfillment. Together, we go above and beyond to make a lasting impact on the lives of our patients and customers. We cultivate an inclusive culture and invite diverse, talented individuals to join us in shaping the future of eye care.
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.