Regulatory Affairs Manager - Abbott Pharmaceutical (Hanoi)

Primary contact with DAV, MOH and relevant Authorities:

- Liaise with government to ensure regulatory compliances.

- Establish and maintain positive relationship with government agencies and other regulatory authorities.

Regulatory affairs’ key focuses:

- Liaise with functional managers to understand their short to medium-term business goals (for example introducing a new product, service, operating process, entering a new market) and develop plans, cost estimates, schedules for acquiring the necessary permits/ approvals.

- Owns ultimate accountability for the function and provide advice, recommendations on company regulatory compliance.

- Ensure the organization regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations/ laws and standards.

- Assure all audits so that organization and government standards on products/ processes are met.

- Consult on ongoing basis on related issues with management team.

- Supervise the registration of marketed product.

- Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution, and sale of Abbott products.

Support to QA, Manufacturing and Marketing activities:

- Provide consultation where needed to Operations, QA and Commercial team on suitability/ acceptability of new product submissions supporting document as per Vietnam regulatory standards.

- Provide regulatory input and support for marketing plans, product launches and other cross-functional activities.

- Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.

Local SOPs and policies:

- Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with Abbott global SOPs & policies and DAV and VN MOH requirements.

SUPERVISORY RESPONSIBILITIES

- Support employees in implementing of their growth plans. Develop and maintain succession plan and address future staffing issues in a proactive manner.

- Manage team’s development throughout the path to achieve goals.

- Ensure team activities to comply with Company Business Code of Conduct and all local applicable laws within scope of function responsibility.

- Special projects as needed by Management team.

Work Experience: >7 years’ experience in Regulatory, prefer pharmaceutical MNC. Experience in leading a team of RA professionals

Education: Bachelor's Degree in pharmacy; Registered Pharmacist in Vietnam.

CORE Skills Required

- Professional Skill

- Ability to handle high levels of pressure and critical decision-making

- Good leadership, interpersonal, teambuilding, and problem-solving skills

- Skilled communicator with well-developed verbal, written and presentation ability

- Strategic thinking

- Planning, Organizing and Coordination

- Ability to learn

- Good Relationship building/ Networking

- Work organization & Priority management