Associate Regulatory Affairs Manager, Pharmaceuticals Division

Job description

JOB DESCRIPTION: 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 Abbott Healthcare business, ensuring compliance to current Vietnam regulatory requirement. Reporting to Regulatory Affairs Manager Working Location: Handi Resco Tower, Kim Ma, Hanoi 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. MINIMUM BACKGROUND/ EXPERIENCE REQUIRED Work Experience >7 years’ experience in Regulatory in pharmaceutical company. Experience in leading a team of RA professionals Education Field of Study-Qualification Bachelor Bachelor's Degree in pharmacy; Registered Pharmacist in Vietnam. CORE Skills Required 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 Apply Abbott Capabilities Framework Language Skill Vietnamese/ Tiếng Việt English/Tiếng Anh Computer Skill (any specific Computer Skill required) MS Office The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: EPD Established Pharma LOCATION: Vietnam > Hanoi : Handi Resco Tower ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)