Senior Regulatory Affairs Specialist, Malaysia

Kenvue Is Currently Recruiting For A:

Senior Regulatory Affairs Specialist, Malaysia

What We Do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S and BAND-AID that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role Reports To:

Director, Metro Asia Regulatory Affairs

Location:

Asia Pacific, Malaysia, Selangor, Petaling Jaya

Work Location:

Fully Onsite

What You Will Do

Who we are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S and BAND-AID that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

What You Will Do

Manage new product registrations and product lifecycle management for cosmetic products, drugs and other consumer health products for Malaysia, Brunei and Singapore, upholding both internal and external quality and compliance standards.

Ensure Local Operating Company complies with the statutory Regulatory, medical and drug safety requirements required by internal policies/procedures and external government legislation/guidelines.

Key Responsibilities

• Regulatory Affairs
• Independently manage the documentation, compilation, preparation and submission of dossiers for new product registration/notification, product amendment, product renewal and variation submissions as per Malaysia, Brunei and Singapore requirement.
• Prioritize assignments and implement regulatory plan and co-ordinate multiple projects and activities accordance with company objectives.
• Ensure timely submission and tight follow up till successful approval, delivering launch plan before or on time.
• Obtain timely renewal of product licenses Responsible for monitoring the status of all license applications Review, approve and provide regulatory advice for product labels/artworks and promotional marketing materials to ensure they are in line with business requirements, compliant to internal process and local requirements/regulations.
• Receive CLCN and CMC variations from the AP RMC and identify if submission to the local Health Authority is required. Strategize and work collaboratively with Global/Regional Regulatory, Commercial, Quality, Supply Chain, R&D teams to deliver timely and commercially advantageous license approvals and ensure regulatory compliance and marketing continuity.
• Requests, organizes, and prepares variation dossier documentation and related fillings to regulatory agencies under planned and approval timeline.
• Updating product registry in all relevant internal systems and trackers and aligning with countries registration submission.
• Monitor relevant regulatory developments in Malaysia, Singapore, Brunei & provide update to Regulatory Affairs (RA) management in timely manner and update the relevant regulatory intel system.
• Assist to research on regulatory related information or updates, compile and presented to RA management whenever required.
• Engage with external stakeholders, e.g NPRA, HSA, PHAMA, CTFA, CTFAS, SAPI for queries, or initiatives.
• External and Internal Management
• Develop and maintain relationships, as warranted, with local Regulatory Agency and other external bodies.
• Use these contacts in lobbying or liaison activities.
• If required, ensure contractors are adequately trained on company processes and policy.
• Ensure Performance Evaluations are carried out in line with guidelines.
  
  

Required Qualifications

What we are looking for

• University/Bachelors Degree or Equivalent in a related field
• 4-6 years of experience in regulatory affairs within the healthcare industry
• Proficiency in Word, Excel, PowerPoint, Email, and Internet applications
• Strong attention to detail with excellent documentation skills
• Experience with Regulatory processes like Drug Listing, IDMP, and Periodic Safety Reporting
  
  

Desired Qualifications

• Registered Pharmacist in Malaysia
• In-depth knowledge of global regulatory requirements and guidelines
• Strong communication and interpersonal skills
• Ability to work effectively in a fast-paced and dynamic environment
• Detail-oriented with excellent problem-solving abilities
• Effective interpersonal skills with a team-oriented and collaborative approach
• Ability to multi-task and deliver high-quality work under pressure
• Adaptability in using appropriate interpersonal styles and techniques to gain acceptance of ideas
• Proven track record of seeking and incorporating stakeholder feedback
  
  

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.