Regulatory Affairs Manager (Regional / CHx MNC)

at  Integrity Partners Pte Ltd

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.

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.

• 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.