Title:  Regulatory Affairs Assistant

Job Summary

Regulatory Affairs (Drug).

General Responsibilities

Operation
- Implementing on getting required product license for drug and pharmaceutical products.
- Arrangement on renewal registration in time without impact on business.
- Consultation with clients and internal teams on regulatory process with requirements including Myanmar label assessment.
- Arrangement on importation of sample, one time permit, redressing permit if required.
- Following up with local authority for on-going process and pending issue if required.
- Preparing and submission of financial advances and claims internally and externally.
- For urgent requirements, assisting and cooperating with other RA colleagues under different division as cross-functional teamwork.

Reporting
- Submission of daily report for registration activity of respective clients to immediate supervisor.
- Submission of status reporting and discussion with client on registration process and requirement.
- Updating regulatory submission and achievement monthly.
- Arrangement on timely submission of AE/ Safety Report and Controlled drug report to local health authority with follow-up action if required.

Management
- Reviewing and management on Regulatory process and system.
- Archiving the documents and inventory in good documentation practice.

Coordination
- Informing the external clients and internal depts. about update procedure, guideline or regulation.
- Cooperation in internal and external audit related to RA and PV with CAPA.

Functional Skills and Knowledge

English Fluency and Computer Literate.
Basic RA Knowledge.

Education and Experience

Bachelor’s degree with English fluency.

Having work experience is preferable.

Why It’s Great to Work at DKSH

At DKSH, we are driven by a purpose that goes beyond the ordinary: enriching people's lives. Through the products and services we provide, DKSH positively impacts millions of lives everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference! https://www.dksh.com/careers.