As a Regulatory Affairs Manager, your primary responsibility will be to lead submission processes and streamline regulatory procedures to secure product approvals across the APAC/Asia/ASEAN markets. Moreover, you will be tasked with fostering collaboration and ensuring compliance with regional regulations.
Role Overview
- Lead the coordination of submission documents and responses to regulatory authority inquiries in diverse markets, ensuring timely approvals for new products and variations.
- Develop and execute submission strategies for regulatory approvals across global regions, facilitating efficient market access and optimizing regulatory success.
- Foster collaboration among key departments to provide regulatory insights and drive regional initiatives, ensuring seamless communication across teams.
- Act as the primary internal regulatory contact, offering support to in-country regulatory teams and distributors across different regions.
- Support the establishment and implementation of standardized regulatory procedures, enhancing operational efficiency across various markets.
Requirements
- Minimum 5 years of experience in local and/or regional regulatory affairs within industries such as pharmaceuticals, food, health supplements, herbal medicines, medical devices, or cosmetics.
- Hold a degree in a relevant scientific field.
- Familiarity with global regulatory frameworks, including comprehensive understanding of clinical, regulatory, registration, and compliance principles.
Interested Applicants
If you're interested in applying for the position, kindly submit your interest with your most relevant CV.
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
