Job Purpose or Summary
Support Pharmacity’s regulatory needs by acting as an interface with the Ministry of Health (MOH) in interpreting laws that may affect Pharmacity, and ensure that regulatory approval of PMC Brand / Exclusives regulated products runs smoothly and timescales optimized and PMC Brand / Exclusives products remain legally compliant at all time.
ORGANIZATION AND TEAM MANAGEMENT
- Develop divisional/departmental organizational structure, job descriptions, budget to perform the company strategies/goals. Ensure periodical review or whenever necessary;
- Develop divisional/departmental and individual KPIs, do alignment with direct line manager and ensure the target achievement;
- Cascade targets to subordinates by assigning KPIs, giving instructions, supporting for achieving the targets and ensuring performance appraisal as requested;
- Build-up and develop the team, organize and assign tasks, manage the team performance; implement the employees’ competence evaluation and have professional development activities to fix gap between the current and expectation;
- Deliver training of processes, procedures, work standards/instructions to subordinates, and ensure the compliance within the delegated function;
- Create best practices for the teams in the systematic approach and ensure activities are delivered in line with these best practices (Includes SOPs, process, policies, work instructions, improvement ideas);
- Motivate, encourage employee engagement and ensure a positive work environment;
- Strive to reach the Company’s Vision and live with our Core Values: Be Cause In The Matter – Integrity – Data Driven – Serve Faithfully – Customer Experience.
REGULATORY AFFAIRS MANAGEMENT
- Support the management team with updates on MOH laws / decisions and summarize weekly.
Support with any queries / clarification needed in a timely manner;
- Ensure we have a process and system to manage and maintain all regulatory documents needed to sell & market Pharmacity Brand & Exclusives where needed;
- Work closely with suppliers to ensure we have dossiers ready to submit on time which have minimal queries;
- Liaise with Ministry of Health to ensure products are approved for sale as soon as possible.
- Explain complex regulatory concepts & provide guidance & technical expertise
- Identify new regulatory trends that could affect future requirements.
- Formulate defensible regulatory strategies and recommendations for complex issues.
- Predict the effect of changes to regulations, policies, or procedures.
- Assess regulatory needs for pre and post-marketing submissions.
- Explain key aspects related to regulation of the product’s development process.
- Create technical documents for submissions, identify gaps & review submissions
- Review labelling and advertising for regulatory compliance.
- Identify the underlying processes and principles for developing product claims.
- Explain data requirements to support product claims.
- University pharmacist degree
- Good English is required as working with suppliers internationally & top management
- 5 years+ in a regulatory role dealing with Vietnamese MOH
- Great networking and relationship skills
- Good communication skills
- Good negotiations skills
- Ability to see the bigger picture and find creative ways to operate within the law
- Business travelling is required