Senior Regulatory Affairs Executive
Department
Regulatory Affairs
Work Location
Lot 1388, Batu 2 1/2, Jalan Kapar, 41400, Klang Selangor.
Date Posted
18 Mar 2025
Responsibilities
- Manage the preparations and submissions of product registration.
- Ensure compliance with the various local and overseas product regulatory requirement.
- Responsible in HALAH application.
- 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.
- Collect and evaluate scientific data that has been researched by R&D team.
- Foster and maintain professional relationship with the health authorities.
- Prepare and monitor submission of license variation and renewals to strict deadlines.
- Advise company on regulatory requirements.
- Project managing teams of colleagues involved with the development of new products.
- Liaise, negotiate, and make presentations to regulatory authorities when necessary.
Requirements
- Possess Degree in Food Technology or equivalent.
- Minimum 2-3 years related experience in regulatory affairs in pharmaceutical industry.
- Familiar with ISO documentation control and GMP
- Demonstrate solid tract records in product registration.
- Self-driven, pro-active and fast learner.
- Able multi-task, reacts swiftly to urgent issues and work within stipulated deadlines.
- Excellent communication, good interpersonal skills and a team player.
Interested applicants are invited to write, fax or email to:
- Fax
+(603)-3342 8285
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