Regulatory Affairs Officer

Requirements : 

• Candidate must possess at least Bachelor's Degree in Pharmacy or equivalent.
• At least 2 Year of working experience in the related field is required for this position.
• Understand GMP Standard for Biotherapeutics Product based on BPOM/EMA/WHO.
• Excellent communicator and deal effectively with all levels/positions.
• Strong leadership and analytical skills.
• English (both oral and written) is a must.

Job Descriptions :

1. To prepare, review and compile registration dossier based on company data file or applicable standard in accordance to local Health Authority requirements.
2. Submit the registration document to local HA in timely manner
3. Follow the registration submission status in local HA, application system
4. Keep updated with new regulatory policies
5. To support and assist Regulatory Affairs Manager as necessary