Head of Regulatory Affairs

Updated: May 12, 2024 04:26 AM GMT

Humankind Group

Hanoi

Role Purpose:

Lead the Regulatory team in Vietnam to develop strategic plan and execute the agreed strategy to deliver business goals. Liaison with officials at DAV (Drug Administration of Vietnam); review, sign-off and submit registrations, deficiency responses, post-approval changes, safety, labelling and annual updates to DAV in the stipulated timelines and in the required format; handle regulatory related matters, provide inputs on regulatory requirements to business and development teams; provide direction and support to regulatory team members.

Within: regulatory requirements and broad organizational guidelines

With the objective of: ensuring timely filing and approval of all regulatory documentation required for smooth conduct of business operations in Vietnam.

Areas of responsibility
• for long- and short-term planning and directing of regulatory activities. Interprets corporate policy, develops and implements strategies for the earliest possible approval of regulatory... More Detail