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 a fast-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
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