Regulatory Executive
2 weeks ago
**Requirements: -**
l Bachelor’s Degree in Science related field e.g. BioTechnology, Chemistry, Science & Technology, Biology, Pharmacology or equivalent.
l Proficiency in English, BM.
l 2-3 years experience in regulatory affairs within a pharmaceutical/ healthcare company.
l Able to work independently & goal driven. Well organized, positive working attitudes, teamwork spirit, self-discipline and great attention to detail.
l Range of age 25-35.
**Monthly S**alary **/ Employee Benefits**:
l RM3,000-4,000 (Depending on the relevant qualification and experience).
l Others: Bonus/Incentive/EPF/Socso/Annual leave/Medical & Personal Accident Insurance Coverage as per legislation requirement and company policy.
**J**ob** **D**escription** **& **Responsibility**:
l Prepare, review, and submit dossiers to regulatory authorities for registration of pharmaceutical products and medical devices.
l Attend to queries posted by regulatory authorities in timely manner.
l Ensure company's products comply with regulatory requirements.
l Review labeling and marketing materials to ensure compliance with relevant regulatory requirements.
l Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
l Attend to Post-Market Surveillance Activities/ Request from regulatory authorities.
**Working hour**:
8.30am to 5.30pm, Monday to Friday
**Report to**:
Regulatory Manager
**Salary**: RM3,000.00 - RM4,000.00 per month
**Benefits**:
- Health insurance
- Opportunities for promotion
- Professional development
Schedule:
- Day shift
Supplemental pay types:
- Performance bonus
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