JOB DESCRIPTION:
ROLES & RESPONSIBILITIES
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's 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.
- To be assigned as SME (Subject Master Expert) of Pharmacovigilance, contact point with PV team in relation to products of Abbott Healthcare Vietnam Co., Ltd
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.
- Special projects as needed by Management team.
MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Work Experience: >7 years’ experience in Regulatory, prefer pharmaceutical MNC. Experience in leading a team of RA professionals
CORE Skills Required:
- 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 & English
Computer Skill: MS office
MINIMUM EDUCATION REQUIRED
- Bachelor's Degree in pharmacy; Registered Pharmacist in Vietnam.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
Vietnam > Thuan An : Binh Duong Plant 1
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)