Regulatory Affairs Executive (Associate Manager Level)

Job & Responsibilities:

• To prepare, review, and compile registration dossier based on company data file or applicable standard in accordance to local Health Authority requirements.
• Prepare administrative document (such as covering letter, statement letter, payment etc.) for registration submission to local Health Authority.
• Submit the registration document to local HA in timely manner.
• To do verification active and inactive material, manufacturer in local HA database; follow up of verification and technical issue related e-registration system to local HA.
• Follow the registration submission status in local HA application system.
• Ensuring all information and data in company database are updated.
• Communicate deficiency/any queries from local HA to principal.
• Submit Response for deficiency in timely manner.
• Keep updated with new regulatory policies.
• Maintain accuracy of product labeling to comply with the global and local requirement.
• Ensure appropriate training has been conducted.
• To support and assist Regulatory Affairs Manager as necessary.

Qualifications & Requirements:

• Bachelor's degree in Pharmacy/ Pharmaceutical Sciences. Having a Pharmacist degree is much preferred.
• Specialized courses or certifications in Regulatory Affairs would be advantageous.
• At least 3-5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology industry.
• Hands-on experience with compiling registration dossiers, submission processes, and interacting with Health Authorities.
• Prior experience in maintaining product labeling to comply with global and local requirements is desirable.
• Comprehensive understanding of local and international regulatory requirements and guidelines related to pharmaceuticals
• Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
• Knowledge and adherence to relevant laws, regulations, and guidelines governing the pharmaceutical, biotechnology, or medical device industry.
• Experience in ensuring compliance with regulatory requirements throughout the product lifecycle, including registration, post-market