Regulatory Affairs Manager / Associate Director with

Location: Osaka / Tokyo, Japan
Industry: Pharmaceutical

Responsibilities:

Engaged with PMDA and Japanese Ministry of Health officials, securing crucial approvals through effective communication.
Optimized regulatory assessment processes for compliance, expediting product development timelines.
Cultivated strong relationships with Global PRA teams across Europe and Asia, fostering seamless collaboration.
Provided expert guidance on Japanese pharmaceutical requirements, bridging international gaps for alignment.
Directed creation of essential pharmaceutical materials, ensuring a smooth regulatory submission process, and oversaw the entire lifecycle of new drug applications, facilitating successful market entry.

Requirements:

Academic background with a scientific degree
Previous experience leading pharmaceutical affairs development, including interactions with regulatory authorities essential
Practical experience in negotiations and effective communication with regulatory bodies mandatory
Proficiency in Business-level English, both in communication and document writing is essential
Experience in global clinical trials advantageous

BeathChapman Pte Ltd

Regulatory Affairs Manager / Associate Director