Regulatory Affairs Executive

GN Neutriceuticals; Subang Jaya; On-site; MYR 200,000 - 250,000; Full time

Job summary

A leading company in the health supplement industry is seeking an Executive for Regulatory Affairs in Subang Jaya. The role involves managing product registrations, liaising with clients, and ensuring compliance with regulations. Ideal candidates must possess a Bachelor's degree and 1-2 years of relevant experience, along with strong attention to detail and communication skills.

Benefits

Yearly increment and performance bonus

EPF, Socso, EIS

Medical Allowance

Attendance Allowance

Qualifications

• 1-2 years of experience in regulatory affairs.
• Strong understanding of Drug Registration Guidance Document (DRGD).
• Independent and detail-oriented individual.

Responsibilities

• Perform product MAL registrations for Health Supplement and TMHS products.
• Liaise and advise clients on product registration requirements.
• Ensure timely renewal of licenses and certificates.

Skills

Regulatory Affairs

Attention to Detail

Liaising with Clients

Knowledge of Drug Registration

Education

Bachelor Degree in Science/Pharmacy/Food

Job description

1. To perform product MAL registrations of Health Supplement Product and
Traditional Medicine (TMHS) Product through Quest 3+ system and
handle Food classifications.

2. To ensure all registrations and feedbacks are executed in a timely
manner.

3. To liaise and advise clients on all product registration requirements.

4. To perform product variations and product renewal for TMHS.

5. To assist with internal audits, audit reports and quality management
systems.

6. To assist with preparation of relevant exportation documents.

7. To liaise with NPRA for all matters pertaining to product registration and
regulatory.

8. To familiarize with registration requirements for both local and foreign
markets.

9. To be up to date with the latest requirements and guidelines from NPRA
and FSQD (BKKM).

10. To ensure the timely renewal of manufacturing license, GMP certificate and
application of Certificate of Pharmaceutical Product (CPP) and Indication
Certificate.

11. To perform change-of-site and change of product registration holder or
product owner accordingly.

12. To perform post-market surveillance by handing in retention samples or
relevant documents to NPRA before due date.

13. To prepare registration dossier based on regulations.

Job Requirement

1. Atleast 1-2 years of experience in regulatory affair work especially in
Health
Supplement Product and Traditional Medicine (TMHS)
2. Have strong understanding of Drug Registration Guidance Document
(DRGD)
3. Age : Below 35 years old
4. Female only
5. Candidate must possess Bachelor Degree in Science/ Pharmacy/ Food or
any related discipline.
6. Independent, cautious, detailed individual.


Benefits
-Yearly increment and performance bonus
- EPF, Sosco, EIS
- Medical Allowance
- Attendence Allowance

- Working days: Monday to Friday
- Working hours: 9:00am - 5.00pm

- Please email resumes to:

Work address and contact numbers are provided below:
GN NEUTRICEUTICALS SDN BHD
NO. 17, JALAN TP3,
SIME UEP INDUSTRIAL PARK,
47620 SUBANG JAYA,
SELANGOR D.E.

TEL: ext (113)
FAX:

Job Info & Requirement

Contract Type Full-time

Job Type Executive

Experience Level 1-3 years, 3-5 years

Job Categories Manufacturing

Candidate must possess Bachelor Degree in Science/ Pharmacy/ Food or any related discipline.

Language Required English, Bahasa Malaysia, Mandarin/Cantonese

Nationality Preferred Malaysians Only

Female Only

Own Transport Car/Van

Salary & Other benefits

RM 3,000 to RM 4,000 per month

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