About the Company
Auriga is an Asian-based integrated market management provider specializing in healthcare. We aim to connect the world's leading healthcare and life sciences companies to care providers and patients across Asia with a comprehensive range of responsible and effective market management solutions.
For over 50 years, we've helped our partners bring essential pharmaceutical, medical devices and life science offerings to Asia with ethical integrity, partnership and transparency. Offering both commercial and logistics solutions, Auriga has operations in Hong Kong, Macau, mainland China, Malaysia, Singapore, Thailand, Indonesia, Brunei and the Philippines. In alignment with our mission to enrich lives with quality care, we distribute more than 500 brands at over 10,000 points of sale.
In November 2017, LF Asia was rebranded as DCH Auriga to signify a new chapter for the company with an exclusive focus on the healthcare industry. Our name is inspired by a constellation known in both the Western and Eastern traditions as the charioteer. It symbolizes our commitment to help our principals navigate market complexities as they explore new opportunities. Auriga represents our mission of stewardship, expansion and growth.
About the Role
The Regulatory Affairs Manager is responsible for leading the Regulatory Affairs (RA) function and ensuring full compliance with applicable laws, regulations, and guidelines issued by relevant Malaysian authorities for all products imported and distributed by DCH Auriga (Malaysia) Sdn Bhd.
This role serves as the Company's Poison License Holder, oversees regulatory services and pharmacovigilance activities, ensures product life‑cycle compliance, and supports commercial teams in business development activities through regulatory guidance, training, and cross‑functional collaboration.
Responsibilities
Regulatory Services, Pharmacovigilance & Controlled Drugs
- Lead and manage all Regulatory Affairs functions and team members in Malaysia.
- Serve as Poison Licence Holder for the Company and ensure compliance with all related requirements.
- Review, approve, and ensure compliance of marketing, sales, and promotional materials with regulatory standards.
- Oversee product registrations, notifications, and approvals (including pharmaceuticals, medical devices, biologics, NCEs, and GMP clearances).
- Guide and direct RA staff to maintain compliance with applicable regulatory, post‑marketing, and audit requirements.
- Manage product life‑cycle activities in accordance with local regulatory requirements.
- Act as the primary person responsible for pharmacovigilance, including adverse event reporting and post‑market surveillance.
- Maintain regulatory databases, including licenses, permits, and approvals from relevant authorities.
- Ensure accurate and timely billing of regulatory‑related services.
- Represent Regulatory Affairs as a member of the Leadership Team.
Regulatory Compliance, Quality & Audits
- Ensure overall business compliance with local regulations, guidelines, and industry codes.
- Support and ensure compliance with Good Distribution Practice, GDPMDS, and other applicable distribution requirements.
- Manage regulatory aspects of advertising, promotion, and sales of healthcare products.
- Coordinate product sampling activities with principals and regulatory authorities when required.
- Lead and participate in internal and external audits, including but not limited to:
- GDP / GDPMDS
- ISO 13485 / ISO 9001
- Precursor audits for psychotropic substances and dangerous drugs
- Support the Company's Quality Management System (QMS) and continuous compliance initiatives.
Training, Medical Support & Business Development
- Conduct regulatory‑related training for sales and marketing teams (e.g. pharmacovigilance, complaints handling, promotional compliance).
- Support Commercial Departments in business development, product evaluation, and pre‑launch activities.
- Represent the Company in pharmacy‑ and regulatory‑related activities organized by authorities or professional bodies (e.g. NPRA, MDA).
- Provide support for clinical and product training to sales teams and targeted healthcare professionals (HCPs).
- Manage medical and product enquiries and lead medical communications.
- Drive medical education initiatives and support educational programs.
Qualifications
- Education : Bachelor's degree in Pharmacy or a related life‑science discipline.
- Licensing : Valid Poison License (or eligible to hold).
- Experience : Minimum 5–8 years of experience in Regulatory Affairs within the pharmaceutical, medical device, or healthcare industry.
- Proven experience in product registration, pharmacovigilance, post‑market compliance, and regulatory audits.
Required Skills
- Technical Knowledge: Strong understanding of Malaysian regulatory requirements (NPRA, MDA, PDMA, poisons and dangerous drugs regulations).
- Leadership & Soft Skills: Strong leadership and people‑management capability.
- Excellent stakeholder management, communication, and cross‑functional collaboration skills.
- Ability to operate effectively in a matrix and leadership‑team environment.
Why Join Us
- Regional exposure within an established healthcare distribution group
- Leadership role with strategic regulatory influence
- Opportunity to shape compliance, quality, and business growth initiatives
We are committed to diversity and inclusivity.
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