Regulatory Affairs Executive 法规事务执行员

About the role

Hai-O Enterprise Berhad is seeking a highly skilled and experienced Regulatory Affairs Executive / Senior Executive to join our team in Klang, Selangor. In this full-time position, you will play a crucial role in ensuring our pharmaceutical and medical device products comply with all relevant regulatory requirements, both locally and internationally.

Responsibilities:

1. Manage the preparations and submissions of all related to product registration matters.
2. Ensure compliance with the various local and overseas product regulatory requirement.
3. Responsible in HALAL application and all related matters.
4. Keep abreast of international legislation, guidelines, and customer practices in all countries that the company is exporting to or customers are exporting to when necessary.
5. Collect and evaluate scientific data that has been researched by R&D team.
6. Foster and maintain professional relationship with the health authorities.
7. Prepare and monitor submission of license variation and renewals to strict deadlines.
8. Advise or update company on regulatory requirements.
9. Project managing teams of colleagues involved with the development of new products.
10. Liaise, negotiate, and make presentations to regulatory authorities when necessary.

Requirements:

1. Possess Degree in Food Technology or equivalent.
2. Minimum 2-5 years of experience in regulatory affairs in pharmaceutical industry.
3. Familiar with ISO documentation control and GMP.
4. Strong understanding of regulatory requirements and processes in Malaysia, as well as key international markets
5. Demonstrate solid tract records in product registration.
6. Self-driven, pro-active and fast learner.
7. Able multi-task, reacts swiftly to urgent issues and work within stipulated deadlines.
8. Excellent communication, good interpersonal skills and a team player.