Senior Regulatory Affairs Officer

Responsibility:

• Preparing regulatory submissions (new registrations, renewals, variations) according to the requirements of Vietnam following guidance from Regulatory Affairs Manager or Regulatory Affairs Deputy Manager if required.

• Communicating with internal and external stakeholders responding to queries and requests with guidance from Regulatory Affairs Manager or Regulatory Affairs Deputy Manager when needed.

• Updating departmental databases and reviewing of RIM records to ensure regulatory compliance.

• Assessing Change Requests for potential regulatory impact.

• Informing all departments when approvals and withdrawals are received, registration/ renewal submissions have been sent.

• Compiling and/or preparing dossier sections, updating dossier sections and document versions, ensuring the validity of information to be submitted for all regulatory submissions.

• Performing harmonisation of product information leaflet and SmPC with originators with Regulatory Affairs Manager or Regulatory Affairs Deputy Manager support to ensure all information is up to date, updating packaging materials and information to be country specific should there be such a requirement.

• Monitoring regulations and guidelines relating to products and registration procedures, informing the relevant departments when necessary.

• Assisting in the preparation of departmental documents such as procedures and/or SOPs.

• Ensuring that tasks and processes are executed according to established regulations and guidelines such as Standard Operating Procedures (SOPs), and the current Good Manufacturing Practices (cGMP).

• Carrying out any other duties as assigned by Regulatory Affairs Manager or Regulatory Affairs Deputy Manager.

• Reviewing and approving Chemistry, Manufacturing and Controls (CMC) related documents (Module 2 and 3 of the dossier) compiled by Regulatory Affairs Officers when assigned by Regulatory Affairs Manager or Regulatory Affairs Deputy Manager.

• Providing support and guidance to the Regulatory Affairs Officers when needed.

• Holding a Bachelor of Pharmaceuticals/Chemistry or similar areas.

• At least 2-3 years of relevant experience after graduation in a similar types of job

• English: fluently in both written and verbal communication

• Ability to work independently, responsible and reliable with minimal supervision.

What we offer::

- Full salary during probation, attractive salary and bonus.

- 5-day working week: Monday to Friday

- 21 days paid annual leave.

- All employee