Regulatory Affairs Manager - Abbott Pharmaceutical (Hanoi)
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
ABOUT ABBOTT
Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were 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 Healthcares 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 teams 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
Education
- Bachelors 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
Behavioral
- Apply Abbott Capabilities Framework
Language Skill
- Vietnamese/ Ting Vit
- English/Ting Anh
Computer Skill
- MS Office
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 > 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)
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
