Senior Regulatory Affairs Associate - Malaysia

PharmaCare Laboratories Pty Limited; Malaysia; On-site; MYR 55,000 - 90,000; Full time

Job summary

PharmaCare Group in Malaysia is seeking a Senior Regulatory Affairs Associate to support regulatory compliance for healthcare products across Malaysia, Singapore, Indonesia and Brunei. You will provide strategic regulatory advice, manage submissions, and ensure ongoing compliance for diverse product portfolios.

The role requires a science-based degree and experience in regulatory affairs with strong emphasis on documentation, classification, and post-market support.

Qualifications

• Experience in regulatory affairs across OTC medicines, listed medicines, foods, cosmetics, devices or related products.
• Ability to prepare, submit, and track regulatory submissions and maintain compliance.
• Strong planning, problem-solving and attention to detail to meet deadlines in a fast-paced environment.

Responsibilities

• Deliver regulatory strategies and submissions for a range of product categories.
• Provide regulatory guidance on product classifications, development and compliance requirements.
• Manage product dossiers, applications and regulatory documentation with internal and external stakeholders.
• Ensure labeling and packaging compliance with regulatory requirements in Malaysia, Singapore and Brunei.
• Collaborate with Brand, Scientific Affairs, Quality and Technical teams to handle inquiries and audits.
• Monitor regulatory changes and maintain accurate records to support ongoing compliance.

Skills

Regulatory affairs

Regulatory submissions

OTC medicines

Labelling & compliance

Stakeholder management

Education

Science-based degree or postgraduate qualification

Job description

Senior Regulatory Affairs Associate - Malaysia

Posted: 28/10/2026

Closing Date: 28/11/2026

Job Type: Permanent - Full Time

Location: Malaysia

Job Category: Regulatory Affairs

About us

At PharmaCare, we are dedicated to enriching people's lives through improved health and wellness. As an Australian born and built success story we are proud of our heritage and remain a 100% Australian owned and family operated business. We have built on our success at home and now have sales and marketing operations around the globe, where we sell and market our well-known and trusted brands.

Our success comes from our performance led culture, and we want our people to succeed. We encourage ownership and integrity with an entrepreneurial flair.

This is more than a job, it’s a chance to be part of something bigger. At PharmaCare, your career can grow alongside brands that are trusted by millions.

Job Description

About the role

As part of the Regulatory Affairs team, this role is primarily responsible for supporting product compliance with legal, statutory, industry and corporate requirements related to the regulation of healthcare products in Malaysia, Singapore, Indonesia and Brunei. This includes strategic regulatory advice, preparing, submitting and tracking regulatory submissions, and maintaining compliance for product portfolios in a solutions-orientate manner in line with business strategies and priorities.

The main responsibilities will include:

• Deliver regulatory strategies and submissions across complementary medicines, registered medicines, medical devices, foods, cosmetics and FMCG products.
• Support new product launches and market access, providing regulatory guidance on product classifications, development and compliance requirements.
• Manage product dossiers, applications and regulatory documentation, identifying and resolving gaps in collaboration with internal teams, suppliers and external agencies.
• Ensure product, labelling and packaging compliance with relevant regulatory requirements and legislation across Malaysia, Singapore and Brunei.
• Partner with Brand, Scientific Affairs, Quality and Technical teams to manage regulatory authority enquiries, post-market assessments and audits.
• Stay ahead of regulatory changes, maintaining accurate systems and records while supporting consultations, reforms and ongoing quality and regulatory compliance.

Desired Skills and Experience

About you

• Hold a Science based degree or postgraduate qualification
• Experience and subject matter expertise in the regulatory affairs (preferably in OTC registered medicines, listed medicines, food, cosmetics, medical device and/or other related products
• Self-driven, results orientated with a positive outlook, and a clear focus on high quality outcomes
• Able to work with minimal supervision with exceptional planning skills prioritising work requirements to meet deadlines in afast-paced marketing environment whilst maintaining a strong attention to detail
• Strong analytical and problem-solving skills, excellent attention to detail and a commitment for compliance processes
• Good written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the BKKM, NPRA, MOH & HSA, Industry Associations and a broad range of internal stakeholders