Job Description

Regulatory Affairs Manager Hub coordinator backup, co-lead Hub specialists, advise on process mapping, facilitating team knowledge sharing. Quality Management (QM):

• Leads the project’s development and/or review of procedures, SOP’s and other documents related to Quality System.
• Maintains Good Documentation practice (GDP) in quality system for new projects.
• Ensures project compliance with all relevant GMP and Quality requirements.
• Manages implementation of Quality system element pertaining to Change Control, Risk Mitigation and validation status as stated in Statement of Work (SOW).

• Ensures all project documentation follow company and regulatory requirements.
• Completes all required reports and administrative tasks within designated timeframes.

• Maintains current knowledge of topics relevant to role, the business and International standards through attendance at seminars, lectures, meetings and professional conferences.
• Maintains knowledge of technological advancements in areas relevant to role.
• Maintains up-to-date knowledge of industry trends, cutting-edge practices and techniques relevant to role and business.
• Ensures all Company related activities comply with relevant Acts, legal demands and ethical standards at all times.

• Risk management (ICH Q9), Pharmaceutical Quality System (ICH Q10), Post-Marketing Changes (ICH Q12).
• Quality Management System tools (PDCA Cycle, FMEA)
• Root Cause analysis and/or Problem-solving approaches.
• Proficient in statistical analysis.
• Project Management Planning.
• Excellent understanding of GxP principles: Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP); and Project Management principles.

• Bachelor’s degree in Science preferably in Pharmacy/Chemistry/Microbiology and Biochemistry
• Expertise: REG expertise/experience on global medicinal products, preferably in APAC (especially SG/MY/HK/KR/Brunei/Macau)
• Minimum of 5 years’ management experience and 10 years in Quality Assurance, Validation or Quality Control roles in the Pharmaceutical/Biotech/Medical device or Life Sciences industry.
• Experience with CQV, Audit and QSC
• Technical Consulting (GDPR, Data Integrity, Cyber Security, etc.) is a plus
• Advanced degrees may compensate for the required experience stated above.
• With sufficient knowledge of spoken and written English.