Michelle Siguji
Summary
Seasoned Regulatory Affairs Officer with over 20 years in developing robust regulatory strategy and effective processes for all products and new initiatives. A collaborator across multi-functional teams providing regulatory inputs and recommendations. Organized and dependable candidate in successfully managing multiple priorities with positive attitude. Strong leader and problem-solver. Encouraging manager with talents for team building, leading and motivating staff.
Overview
24
24
years of professional experience
Work History
Snr Regional Regulatory Manager
Procter & Gamble Co
03.2020 - Current
- Contributed to business growth in Personal HealthCare through robust regulatory strategy for the AMA region, enabling the successful launch of innovative products in various categories: medicine, health product, medical device, health supplement, food.
- Compiled regulatory dossiers for LRA submissions in respective countries and monitored regional submissions and approvals status.
- Monitor regulatory intelligence regionally and globally and stay current on emerging trends and changes in the regulatory landscape.
- Project manager and collaborator across various projects in AMA region collaborating with multiple functional teams at local and regional levels, providing regional regulatory expertise and guidance.
Regulatory Affairs Manager
Moleac
08.2018 - 02.2020
- As the global regulatory manager and strategist, coordinated with distributors in each market to ensure compliance with regulatory requirements during pre-and post-market approval of product, NeuroAid.
- Provided responses to regulatory agencies regarding product information or issues.
- Recommended improvements to processes.
- Streamlined submission processes for improved efficiency and timely approvals from regulatory agencies.
Head of Regulatory Affairs
Bayer Pharmaceuticals
10.2014 - 07.2018
- Gained strong leadership skills by managing a team of 8 staff, and for various product registrations across different sectors: pharmaceutical and consumer care.
- Delivering early drug/product approval and ensuring regulatory compliance for all registered products.
- Strategic planning for regulatory strategies for the countries.
- Local SOP writing and regulatory governance for the sub-region Malaysia, Singapore, Brunei. Laos, Myanmar.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
Regulatory Affairs Manager
Bayer Pharmaceuticals
02.2011 - 09.2014
- Managed local RA team and worked with multi-functional team to accomplish regulatory goals and achieve full compliance with all products.
- Developed strong relationships with key stakeholders, facilitating open communication channels between organizations.
- Monitored competitor activities within the industry landscape, informing strategic decision-making processes accordingly.
Regulatory Affairs Manager/Executive
Boehringer Ingelheim
06.2004 - 01.2011
- Oversaw timely preparation and submission of high-quality documentation for product registrations, variations and renewals.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
- Performed all pharmacovigilance monitoring and reporting.
Scientific Information Manager
Roche
01.2004 - 06.2004
- Involve in drug safety reporting and clinical trial research work.
Pharmacist Manager
Guardian
04.2000 - 09.2003
- Managed the retail pharamcy through inventory management strategies to minimize waste and maximize cost savings and overseeing staff productivity and efficiency in day-to day operations.
- Empowered staff through delegation of responsibilities while maintaining oversight over critical functions within the Pharmacist Manager role.
- Promoted pharmacy services to patients and medical providers.
- Ordered all pharmacy supplies and kept check on inventory levels.
- Optimized workflow processes, resulting in increased efficiency and productivity within the pharmacy team.
Education
Bachelor of Science - Pharmacy
National University of Malaysia
Malaysia03.2000
Skills
- Regulatory strategist
- Dossier submission preparation
- Document Management
- Regulatory Agency Applications
- Product Lifecycle Management
- Project Oversight & Management
- SOP Development
- Risk Management
- Regulatory Intelligence Landscaping
- Operational planning
- Employee Development
- Conflict Resolution
- Problem-Solving
- Excellent Communication
- Multitasking
- Analytical and Critical Thinking
- Organizational Skills
- Teamwork and Collaboration
- Attention to Detail
Timeline
Snr Regional Regulatory Manager
Procter & Gamble Co
03.2020 - Current
Regulatory Affairs Manager
Moleac
08.2018 - 02.2020
Head of Regulatory Affairs
Bayer Pharmaceuticals
10.2014 - 07.2018
Regulatory Affairs Manager
Bayer Pharmaceuticals
02.2011 - 09.2014
Regulatory Affairs Manager/Executive
Boehringer Ingelheim
06.2004 - 01.2011
Scientific Information Manager
Roche
01.2004 - 06.2004
Pharmacist Manager
Guardian
04.2000 - 09.2003
Bachelor of Science - Pharmacy
National University of Malaysia
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