Regulatory Affairs Associate

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

Primary Function

The position performs the preparation and administrative portions for the different regulatory services and deliverables and support department relative contributes, e.g. the regulatory projects or Intelligence.

Key Responsibilities

Project Execution

• Support and perform the preparation and administrative portion for different regulatory services, included but not limited to CTD authoring customization and integration, CTD document preparation and publishing, country paper and electronic submission, gap analysis customization and integration, consultation meeting arrangement, Regulatory project coordination supports and support the liaison with Authority according to the regulatory requirements, service scope and client’s expectation.
• Provide administrative/coordination support and perform regulatory activities including the preparation for the initial submissions and the life cycle for the clinical study and product licenses.
• Check and collect the regulatory updates and support the regulatory intelligence update.

Commercial Support

• Support department to prepare the description for proposed Regulatory Service and/or the sales presentation

Support department to contributes information for the account planning process and integrated marketing programs

• 0-2 years RA related experiences or different subject matter, e.g. Regulatory operation, CMC or non-clinical discipline and/or eCTD publishing/submission tasks
• Understanding country regulatory infrastructure and global standard, e.g. ICH guideline
• Good communication, organization, attention to detail.
• Ability to work effectively with internal and external team.

Ability to communicate and write English clearly, concisely, and effectively.

Education Required

Bachelor’s degree or above in life science, pharmacy, medical or industry related discipline (pharmacology, pharmaceutical analysis, biological science, cell and molecular biology, molecular engineering, chemical engineering or medical related)

Language

fluent in both English and Chinese