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The Associate Director, Regulatory Liaison position at 539 is a hybrid role focused on overseeing regulatory strategy for product development and health authority interactions across the Asia Pacific region. The ideal candidate should possess a strong background in Regulatory Affairs with at least 10 years of experience, combined with excellent communication and problem-solving skills.
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Job Summary
The role serves as the single point of contact for specific products between countries and headquarters while leading regional regulatory strategy.
Responsibilities include managing Health Authority responses, addressing deficiency letters, and ensuring alignment of product portfolio priorities with stakeholders.
The position requires a candidate with substantial industry experience who can independently manage complex challenges across cross-functional international teams.
Matching Summary
Match Score: 75
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The Associate Director, Regulatory Liaison position at 539 is a hybrid role focused on overseeing regulatory strategy for product development and health authority interactions across the Asia Pacific region. The ideal candidate should possess a strong background in Regulatory Affairs with at least 10 years of experience, combined with excellent communication and problem-solving skills.
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Skills & Requirements
Must-have
Bachelor degree in Pharmacy or related discipline
10 years experience in Regulatory Affairs
Fluent written and spoken English required
Nice-to-have
Strong collaborative skills
Ability to work proactively in fast-paced environment
Experience within Asia Pacific region preferred
Key Requirements
Bachelor graduate degree in Pharmacy, Biological Sciences, Chemistry
At least 10 years' experience in Regulatory Affairs
Solid knowledge of registration guidelines for NCEs