Regulatory Affairs Manager for International Markets

2 weeks ago


Shah Alam, Selangor, Malaysia Clinigen Full time

Clinigen's rapid growth presents a unique opportunity for a skilled Regulatory Affairs Manager to make a meaningful impact on our international markets. As a key member of our Asia Pacific team, you will be responsible for driving regulatory compliance across new product registrations and variations within assigned portfolios and territories.

Your primary focus will be on managing the preparation and submission of high-quality regulatory documents to regional health authorities, upholding the highest standards of accuracy, clarity, and compliance.

To excel in this role, you will need:

  • A strong understanding of regulatory frameworks in South East Asia, particularly HSA and NPRA
  • Proven experience in regulatory affairs roles, with a minimum of 5 years' tenure in the region
  • Excellent communication and project management skills

We offer a dynamic work environment, competitive compensation, and opportunities for growth and development.



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