Hanoi - Regulatory Affair Manager

To 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), MOH 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. 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:
• Responsible 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 submission, advises and manages the regulatory teams, and reviews ongoing projects for Pharma, OTC, Medical Devices, Derma & Aesthetics, Nutrition Supplements, Traditional medicine, Biologics, etc.
• Plans, schedules and directs activities and programs through regulatory staff.
• Work with both internal and external stakeholders, outside agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of product and services.
• Coordinate and/or represent the Company in meetings with government officials, administrators, regulators and business associations. Establish networks with senior level authorities in DAV and key stakeholders to provide information and explanations on business policies and practices, seek their support during major issues and provide them explanations and information IN ORDER TO ensure healthy relations with regulatory authorities to enable timely approvals of registration and manage related regulatory issues effectively.
• Develop and execute a strategy and stakeholder engagement plan to accomplish these objectives.
• Reviews and prepares responses to inquiries from regulatory authorities relating to product registrations.
• Oversees the preparation and submission of applications, responses to inquiries from regulatory authorities relating to product registration and other regulatory related matters.
• Coordinate with local partners and head office QA team to ensure QA related requirements and matters to be managed well with full compliance to local regulations and company policies and guidance.
• Manage routine reports/renewals, including the preparation and submission of supplements
and amendments as required by internal department. (Manufacturing, QA/QC, Medical, etc.)
to update registered product information.
• Understand existing and monitor evolving Government policies and legislation, determine their potential impacts on business, freedom to operate, or new opportunity.
• Monitors ongoing legislative and regulatory developments and updates local registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel; provide timely analysis of their relevance to the business and management team.
• Communicates pertinent changes and updates to regulatory staff and senior management.
• Ensure all documents and operation in regulatory affairs to follow companies policies, procedures and comply to local laws and regulation.
• Co-ordinate with internal and external stakeholders and lead RA team to provide support and needful actions for audit purposes
• Develop Regulatory team to strengthen capability and competencies.