Regulatory Affairs Associate: Submissions & Coordination

HiRO - Harvest Integrated Research Organization; Penang; On-site; MYR 40,000 - 50,000; Full time

Job summary

A leading regulatory services organization in Penang, Malaysia is seeking a candidate for a role focused on the preparation and administration of regulatory services. Key responsibilities include supporting project execution, managing submissions, and coordinating regulatory activities. The ideal candidate will possess a Bachelor’s degree in a related field and have strong communication and organizational skills. Fluency in English and Chinese is essential. This entry-level position offers opportunities to grow within the regulatory field.

Qualifications

• 0-2 years of regulatory affairs related experience or different subject matter.
• Understanding of country regulatory infrastructure and global standards, e.g., ICH guidelines.
• Ability to communicate and write clearly and effectively in English.

Responsibilities

• Support and perform preparation for regulatory services and submissions.
• Provide administrative support and perform regulatory activities for clinical studies.
• Collect regulatory updates and support intelligence updates.

Skills

Regulatory operations understanding

Communication skills

Organization skills

Attention to detail

Ability to work in teams

Fluency in English and Chinese

Education

Bachelor’s degree in life science or related field

Job description

A leading regulatory services organization in Penang, Malaysia is seeking a candidate for a role focused on the preparation and administration of regulatory services. Key responsibilities include supporting project execution, managing submissions, and coordinating regulatory activities. The ideal candidate will possess a Bachelor’s degree in a related field and have strong communication and organizational skills. Fluency in English and Chinese is essential. This entry-level position offers opportunities to grow within the regulatory field.