· Regulatory service, Product Life Cycle and Regulatory Strategy Management.· Feasibility Studies and GAP analysis.· Quality, Compliance and GMP Management.· Clinical Trials and Bio-equivalency or Bio-Similarity management.

Leading clinical studies and managing project of clinical trials with a high level of project management to meet the business target.

Achievements:* Saved $108,000.00 in a year from QC department.* Increased efficiency by 20% through implementing Enterprise Empower System.* Increased release rates by 30% and decreased turnaround time by 40% through highly effective work management. * Managed and ensured required analysis of raw materials, in-process materials, packaging materials and finish products are completed on time and all the work are being conducted in accordance with TMs,SOPs, policies and practices, cGxP, ICH Q7 and international codes of cGMP.* Successfully passed TGA audit with only two minor observations. * Built the work culture of strong work ethic, result oriented and positive attitude to face all the challenges.

Lead to develop and establish successful Research & Development (R&D), Regulatory Affairs (RA) and Project/Program Management (PM) teams from scratch level for developing, submitting and managing products/projects in most types of pharmaceuticals dosage forms for TGA, FDA, EMA and MHRA.

Performed quantitative and qualitative analysis of raw materials, in process and finish products.