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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.…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.

Stephanie Mae Lim

Project Manager, Production Manager, Content Strategist, +2

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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.…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.

Available to hire

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.

Skills

Leadership

Data Visualization

Experience Level

Leadership

Expert

Data Visualization

Expert

Language

English

Fluent

Malay

Advanced

Chinese

Advanced

Work Experience

Regional Regulatory Affairs Manager at Zuellig Pharma

April 1, 2022 - Present

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, Malaysia and Brunei at Zuellig Pharma Malaysia

April 1, 2021 - June 30, 2022

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).

Regulatory and Pharmacovigilance Manager, Malaysia and Brunei at Zuellig Pharma Malaysia

January 1, 2020 - March 31, 2021

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.

Regulatory Affairs Manager, Malaysia and Brunei at Zuellig Pharma Malaysia

February 1, 2019 - December 31, 2019

Consolidated regulatory departments; oversee Regulatory Services (Registration, Product Maintenance) and Regulatory Affairs (PV, Post Marketing, Import Licences, Quotas, Recalls); audit involvement; two reporting lines to GM and CEO.

Regulatory Affairs Manager, Malaysia at Zuellig Pharma Malaysia

September 1, 2018 - January 31, 2019

Oversee regulatory services and regulatory affairs operations for Malaysia; accountable for registration and product maintenance, PV activities, import permits, recalls, etc; involved in audits and CAPA; two reporting lines to GM and Chief Executive for Operations clients.

Chief Pharmacist/Business Development Manager at Sun Healthcare

July 1, 2014 - January 31, 2017

Led pharmaceutical arm; established SOPs; responsible for business development, client negotiations, and product training for marketing and sales; conducted overseas client communications and regulatory product evaluations; built B2B/B2C negotiation experience.

Head of Department, Outpatient Pharmacy at Hospital Lahad Datu

December 1, 2012 - October 31, 2013

Led outpatient pharmacy; supervised up to 15 staff; prepared reports and research for Ministry of Health; ran MTAC for Warfarin and Diabetes; measured patient satisfaction and implemented process improvements; optimized prescription retrieval system.

Pharmacist / Branch Manager at Health Lane

November 1, 2013 - June 30, 2014

Maintained day-to-day pharmacy operations; managed staff; stock management; customer counseling; contributed to audits and stock transfers; ensured service targets; provided training and supervision.