Senior Regulatory Affairs Executive

• 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

• 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