**ABOUT ABBOTT** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **WORKING AT ABBOTT** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: + Career development with an international company where you can grow the career you dream of. + A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. + A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **_MAIN PURPOSE OF ROLE:_** + Plan, direct, and monitor regulatory affairs so that the organization has the permits, license, certificate, authorization, and other approvals it needs to conduct its current and future business activities. + Maintain local SOPs and Regulatory policies and provide support to Glomed business, ensuring compliance to current Vietnam regulatory requirement. **_MAIN RESPONSIBILITIES:_** + **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. **_SUPERVISORY RESPONSIBILITIES_** + **People Management:** + 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. **_MINIMUM BACKGROUND/ EXPERIENCE REQUIRED_** **_Work_** **_Experience_** >7 years’ experience in Regulatory, prefer pharmaceutical MNC. Experience in leading a team of RA professionals **_Education_** _Education Level_ _Field of Study_ _-Qualification_ Bachelor + Bachelor's Degree in pharmacy; Registered Pharmacist in Vietnam. **_CORE Skills Required_** **_(Top 4-6 Skills / Competencies required for role)_** _Professional Skill_ _Technical skills required for role_ + 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 _Behavioral / Leadership Skill_ _Competencies required for role_ Apply Abbott Capabilities Framework _Language Skill_ + Vietnamese/ Tiếng Việt + English/Tiếng Anh _Computer Skill_ _(any specific Computer Skill required)_ + MS Office An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com