Senior Regulatory Affairs Executive

Requirements: Experience in GMP, HACCP & regulatory affair matters related to nutraceutical industries (health supplements, food supplements & traditional medicine). Bachelor in any science discipline preferably (Pharmacy, Science or related fields). At least 3 years working experience.

Benefit EPF + SOCSO + EIS Health Supplement Medical Claim Annual Leave Compassionate Leave Paternity/Maternity Leave Sport Benefit Dental Benefit Scopes: Document preparation for product registration in Quest3+ (Health Supplements & Traditional Medicine). New product registration application for homebrand (Traditional Medicine) and OEM (TMHS). MSC Digicert Trustgate Token application & renewal.

Product variation for traditional medicine & health supplements (homebrand & OEM). Product label checking (Food & TMHS). Application for food labelling screening and advisory, BKKM.

Medicine advertisements, KKLIU application.

Artwork checking & confirmation for new product order.

Coordinate with R&D, QA/QC and Sales & Marketing department for sample submission purpose.

Liaise with HOD & Account department & keep up to date all renewal payment promptly in time.

Receive, record, process any non-conformance product recall issues that arises from public or authorities.

Correspondence reply with all NPRA officers on any issues regarding regulatory applications.

Providing support in achieving and follow up on implementation of whole operation in the RA department.

Provide product write-up when needed by Marketing.

Product renewal for pharmaceutical and cosmetics.

Notification note application for cosmetic.

License renewal.

Indication certificate application.

Working Hours Monday – Friday: 08:30 AM – 05:30 PM Work Location EXCEL HERBAL INDUSTRIES SDN.

BHD.NO.

48 & 49, Jalan Velox 2, Taman Velox, Rawang Industrial Park, 48000 Rawang, Selangor Experience Required: Min 3 Year/s