Stephanie Mae Lim
I am Stephanie Mae Lim, a Regulatory Affairs professional with 13 years of experience spanning regulatory compliance for biologics, small molecules (NCE), OTC, supplements, cosmetics and medical devices.
About
I am Stephanie Mae Lim, a Regulatory Affairs professional with 13 years of experience spanning regulatory compliance for biologics, small molecules (NCE), OTC, supplements, cosmetics and medical devices. I excel at building high-performing, reliable teams and collaborating with internal stakeholders to support regulatory compliance across ASEAN. I currently lead two teams (10 people) at Zuellig Pharma and drive regulatory strategy, PV oversight, and licensing for distribution networks.
I have written and revised numerous SOPs and guided >50 clients across the USA, Switzerland, UK, Korea, Japan and Australia. I enjoy partnering with supply chain, marketing and sales to align regulatory activities with commercial plans, liaising with MOH for accurate dissemination of regulatory information, and leading negotiations with new clients. I am passionate about pharmacovigilance, post-marketing compliance, and building robust regulatory processes that support business growth.
- 12 years' experience
- Joined April 2026
Skills· 2
Languages
- EnglishFluent
- MalayAdvanced
- ChineseAdvanced
Industry experience
- Healthcare
- Life Sciences
- Professional Services
Work experience· 8 roles
Regional Regulatory Affairs Manager leading two teams (10 staff) in the ASEAN region; governs regulatory strategies for biologics, small molecules, OTC, supplements, cosmetics, and medical devices; liaison with regulators (MOH) and clients; oversight of pharmacovigilance and post-marketing activities; negotiates PVAs/SDEAs; ensures regulatory compliance across distribution and licensing.
Head of Regulatory for Malaysia and Brunei; oversee regulatory submissions, harmonization of regional projects, provide input to Sales/Marketing, ensure importation and distribution compliance; manage team of 10 (3 in Brunei).
Oversee Regulatory, Registration, and Pharmacovigilance for Pharmaceuticals and Medical Devices for Zuellig Pharma; set up pharmacovigilance processes, PV department, PVSS and PSMF; review PVAs and SDEAs; involved in audits and CAPA; two reporting lines to GM of Commercial Solutions and Regional Regulatory Director.
Education
Certifications and awards
Hire Stephanie Mae Lim today
Post a job and invite Stephanie, or contact them directly. No hidden commission.