Supervisor, Regulatory Compliances

Job Summary

The role of Supervisor, Compliances is to coordinate the preparation of project proposal and/or applications in line with required technicals, standards, regulations and administrations for submission to relevant institutions including government ministries in response to timelines.

Key Responsibilities

1. Prepare project proposals and/or applications in line with requirements on a timely manner to ensure that the proposal and application is accurate, complete, current and submitted within the allowed deadlines.
2. Compile comprehensive registration dossiers containing technical documents, compliance declarations, and supporting certificates (e.g., GMP, CoA) to ensure that requirements are met.
3. Review and verify relevant required pharmaceutical documentation including pharmaceutical product, good manufacturing practice, ISO, Certificates of Analysis (CoA), Safety Data Sheet, prior to submission of the proposal to ensure that relevant technical requirements are met.
4. Evaluate drug samples and related medicinal products as required with the preparation of reports for references to ensure that required products meet the requirements.
5. Provide timely and accurate responses to clarify any question from the evaluation and/or bidding committee to ensure that the responses are accepted and on time.
6. Prepare and deliver presentations, provide additional samples, or supplementary information when requested to ensure that requirements are met.
7. Provide training to relevant stakeholders on requirements for compliances to ensure that they are understood of the requirements.
8. Review compliance requirements of the companies and prepare applications for submission to relevant governmental ministries to obtain the permit to ensure that the company is operated in compliance with the regulations.
9. Assist in the preparation for internal and external ISO audits and other audits to ensure that there is no issue with the requirements and that actions shall be taken for continuous improvements.
10. Assist in the registration of products as required by the standards and regulations to ensure that the product is eligible for being sold to the markets.
11. Assist in the preparation and submission of an application for the request for a permit to ensure that the compliance is operated in adherence to the standards and regulations.
12. Perform other tasks as required.

Success Factors

1. Be able to work with cross Functions
2. Demonstrate detail-oriented attitude
3. Work under pressures with tight deadlines
4. Deal with governmental ministries

Qualifications

1. Education:
   • Bachelor’s degree or equivalent; preferably, in Medicine, Pharmacy, Business Administration, Accounting and Law.
2. Experiences:
   • Minimum 3 year working experience in compliance work.
3. Skills and knowledge:
   • Good interpersonal, communication and customer service skills
   • Facilities maintenances skill
   • Ability to solve the problem
   • Ability to work under pressure and hot atmosphere
   • Computer literacy (Microsoft office)
   • Language: Good command of Khmer and English