Sr. Associate, Regulatory Affairs Strategy (APAC)

Alcon Laboratories Malaysia Sdn Bhd; Selangor; On-site; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation package

Comprehensive benefits

Learning and development opportunities

Global medical device leader

Job summary

Alcon Laboratories Malaysia Sdn Bhd is seeking a Sr. Associate, Regulatory Affairs Strategy (APAC) to support the regulatory function across product lifecycle management and ongoing maintenance. You will drive registrations, lifecycle activities, and coordination with local teams in APAC.

Ideal candidates have a degree in engineering, pharmacy or sciences, fluent English, familiarity with APAC languages is a plus, and the ability to work independently in a dynamic, international environment.

Qualifications

• Degree in Engineering or Pharmacy or Science or related scientific discipline or equivalent.
• Fluent in English in both oral and written form.
• APAC languages (Korean, Japanese, Thai) a plus.
• 1–2 years of Regulatory Affairs experience preferred; fresh graduates considered.
• Strong interpersonal and communication skills; able to work in an international environment.
• Independent, proactive, able to meet tight deadlines and solve problems.

Responsibilities

• Drive Product Registration, re-registration, change notifications and license applications & maintenance.
• Drive product lifecycle management activities (labeling changes, new regulation assessment and preparation, CPDS, promotional material reviews).
• Manage administrative and coordination activities (project metrics, archival licenses/ permits, invoice and payment tracking, operational support).
• Provide regulatory support to local teams.
• Support newcomer onboardings.
• Review promotional materials for compliance with regulations in assigned markets.

Skills

English fluency

APAC language awareness

Education

Degree in Engineering or Pharmacy or Science or related discipline

Tools

Excel

PDF

Job description

Sr. Associate, Regulatory Affairs Strategy (APAC)

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

Key responsibilities

• 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
• Provide regulatory support to local teams
• Support newcomer onboardings
• Review of Promotional Materials for compliance with regulations in assigned markets

About you

• Degree in Engineering or Pharmacy or Science or related scientific discipline or equivalent
• 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
• 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
• Computer literate and knowledge of Excel and PDF

About us

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. We cultivate an inclusive culture and invite diverse, talented individuals to join us in shaping the future of eye care.

• 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