Regulatory Affairs Executive

Responsibilities

Ensure all products are notified / registered on time based on product roll-out plan.

To monitor periodically notification number expiration date and renew accordingly to ensure all products available on the market are with a valid notification number at all time.

Ensure PIF are completed on time and maintained in a good manner according to requirement of ACD and are strictly kept confidential.

Coordinate and ensure timely approval of SIRIM certification upon shipment arrival.

Manage, monitor, and ensure timely renewal of all company licenses.

Work closely with product development team and principals (for distribution brand) to provide regulatory advice on formulation to ensure ingredient used are permitted and in appropriate dosage.

Assist in correspondence with the authorities on enquiries in timely manners, including sample preparation, PIF audit and drafting feedback letter.

Participate and contribute inputs in relevant trade associations for the benefit of consumers and the industry (CTFA).

To furnish relevant document and communicate with supplier to obtain Halal Certification when required.

To furnish relevant document and communicate with regional personnel to ensure timely registration in these markets.

To check and advise Marketing artwork in relation to product label claims, use and other regulatory requirement as stipulated by the competent authority of the relevant country.

To contribute idea or advice in term of product marketing claim to meet business objective yet with full compliancy to the stipulated regulation

Requirement

Possesses a degree in science or any related discipline.

Good command of English and Bahasa Malaysia.

Ability to use Microsoft software (Words, Excel & Power Point) and e-mail.

Possesses 1-2 years experiences in handling regulatory related matters.

Knowledge in cosmetic, pharmaceutical, OTC, health supplement and traditional medicines requirement will be an added advantage.

Able to interpret well regulatory guideline and communicate correctly and efficiently to relevant team member.

Self-motivated, meticulous, detail-oriented, able to multitask and a good team player.