Job Description
Are you a detail-oriented professional with a passion for regulatory compliance within the healthcare and FMCG sectors? Our organization is looking for a dedicated Regulatory Affairs Executive to join our team in Selangor. In this role, you will be instrumental in ensuring our health supplements and FMCG products meet all stringent local and international regulatory requirements, enabling seamless product registration and market entry.
The successful candidate will serve as a vital link between our product development team and regulatory authorities, ensuring that all submissions are accurate, compliant, and processed in a timely manner. If you possess a keen eye for detail, strong communication skills, and a desire to grow within the healthcare industry, we invite you to apply.
Responsibilities
- Manage the end-to-end product registration process with local health authorities (NPRA).
- Maintain and update regulatory dossiers to ensure ongoing compliance for health supplements and FMCG products.
- Monitor and analyze changes in local and international regulations to advise internal stakeholders.
- Coordinate with cross-functional teams to review marketing materials and labeling for regulatory adherence.
- Liaise with regulatory bodies and external consultants to resolve queries and facilitate product approvals.
- Prepare, compile, and submit high-quality regulatory documentation within specified timelines.
- Conduct internal audits to ensure standard operating procedures (SOPs) are strictly followed.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 1-3 years of experience in regulatory affairs, preferably within the health supplement or FMCG industry.
- In-depth knowledge of NPRA guidelines and local health regulations.
- Strong analytical skills with the ability to interpret complex regulatory requirements.
- Excellent verbal and written communication skills in English and Bahasa Malaysia.
- Proficiency in document management systems and Microsoft Office Suite.
- Ability to work independently and manage multiple projects simultaneously under tight deadlines.