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Regulatory Affairs Specialist

2 weeks ago

Petaling Jaya, Selangor, Malaysia Nexus Wise Sdn Bhd Full time 40,000 - 60,000 per year

Minimum Qualification : Graduated in Bachelor's Degree in Life Sciences such as Food Science, Nutrition etc.

Years of Experience       : Minimum 1-2 years in Regulatory Affairs / Quality Assurance / any position with MAL submission experience

Location : Petaling Jaya, Malaysia

Company : Nexus Wise Sdn Bhd

Working Hour : Monday to Friday (9.00am - 5.30pm)

Benefit : Annual Leave, Medical, Sport Allowance, etc

About Us

Nexus Wise is a leading nutraceutical ingredient distributor and solution provider in Asia. We are on the lookout for a passionate and experienced Regulatory Affairs to be part of our dynamic team. If you thrive in a fast-paced environment and are eager to contribute to a company that values growth and efficiency, this is the perfect opportunity for you

Key Responsibilities:

We are looking for an Regulatory Affairs Specialist with knowledegable in NPRA and KKM regulatory frameworks and application systems to join our team

Key Requirements:

Knowledge & Experience

  • Candidate must possess at least graduated in Bachelor's Degree in Life Sciences such as Food Science, Nutrition etc.
  • At least Minimum 1-2 years in Regulatory Affairs / Quality Assurance / any position with MAL submission experience

Skills

  • Dossier preparation and submission
  • Proficiency in application system such as QUEST3+ system
  • Interpreting technical document
  • Literature review and data interpretation
  • Compliance evaluation
  • Project planning and progress tracking

Abilities

  • Attention to detail and accuracy
  • Effective communication in English, Malay, and Mandarin
  • Able to analyze and resolve regulatory challenges logically
  • Able to manage multiple projects and prioritize tasks effectively
  • Collaborative team player with initiative and accountability
  • Able to work independently with minimal supervision
  • Continuous learning mindset

Responsibilities

Product Registration & Submissions

  • Prepare and submit dossiers for MAL registrations and manage post-registration activities such as Variation, COH, etc.
  • Manage food classification, KKM label advisory, and handle pet food registrations, ensuring full compliance with regulatory requirements.
  • Handle regulatory submissions to Singapore HSA, including document preparation and coordination.
  • Liaise with NPRA, KKM, HSA and other authorities as required.
  • As required, to attend training or meetings with regulatory officers for compliance or technical discussions.

Project Coordination & Advisory

  • Liaise with OEM manufacturers and external laboratories on trial runs, testing, and documentation.
  • Coordinate with internal teams and customers during dossier and label review cycles.
  • Provide advisory support for regulatory submissions and compliance.
  • Support other administrative activities as assigned.

MAL Product Development

  • Initiate and develop new MAL product concepts by conducting comprehensive literature reviews, evaluating scientific evidence, and analyzing market trends.

Documentation & Compliance

  • Review and prepare technical documents for regulatory submissions.
  • Conduct label reviews to ensure compliance with relevant guidelines.
  • Maintain proper filing and records of dossiers, submissions, and approvals.

Why Join Us?

  • Be part of a leading company in the nutraceutical industry.
  • Work in a collaborative and dynamic environment.
  • Gain experience in supply chain management, vendor coordination, and customer engagement.
  • Transportation Allowance, Cost Living Allowance, Dental & Optical, Sports Allowance and Parking Allowance.
  • Opportunities for professional growth and development