Regulatory Affairs Executive (9 Months)

Contract position for coverage during maternity (9 months)

• Location: Jalan Bersatu 13/4, Section 13, 46200 Petaling Jaya, Malaysia
• Monday - Friday 8.30am - 6.00pm
• RM2200
• A degree qualification of minimum Diploma of Science is compulsory

Scope of Responsibility:

This position will be responsible as the Regulatory Affairs executive assisting the SAH Regulatory Affairs Manager in managing regulatory affairs matters related to products imported and marketed in SAHwhich includes product notification and registration with the respective health authorities and also halal certification application management with the relevant Halal certification bodies.

Specific Responsibilities:

• As Regulatory Affairs Executive, under the instruction & guidance of the
• SAH Regulatory Affairs Manager
• Assist in timely product registration/notification submission and also
• Halal certification. This includes compiling, reviewing & filing of dossiers
• for the registration/notification submission & also Halal certification.
• Assist SAH Regulatory Affairs Team maintain Product Information File
• (PIF), technical information as well as other Regulatory documents in
• accordance with the provisions of the relevant regulations, in soft
• and/or hard copy
• Ensure correctness and completeness of Regulatory information
• required for product procurement
• Provide support to SAH Regulatory on other regulatory & halal
• administrative matters as instructed by the Regulatory Manager.
• Ensure proper archiving of all documents submitted to and received
• from Authorities, as well as accurate and timely data update of
• regulatory compliance databases and tools for assigned products.
• Ensure participation in key meetings for the regulatory function and
• provide timely feedback.
• Review product label artwork and advertising materials
• Engage with relevant government agencies, as and when required to
• support daily operations
• Support Regulatory Affairs manager on administrative and other
• Regulatory tasks when required
• With the guidance of SAH RA manager, support the SAH Regulatory

Team in responding to enquiries and challenges from health authorities