Associate Regulatory Affairs Manager - Abbott Pharmaceuticals

Associate Regulatory Affairs Manager - Abbott Pharmaceuticals

Abbott Ensure
3-6 years
Not Specified

Job Description


JOB DESCRIPTION:

JOB DESCRIPTION

MAIN PURPOSE OF ROLE
. Product registration including new, renewal, variations, special import license, promotional materials
. Do regulatory activities to support product circulation in the market i.e. tender support, GMP listing, stock management
. Other tasks assigned by the line manager.

MAIN RESPONSIBILITIES
. 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.
. Coordinate with manufacture, region and prepare dossier for product registration (drug, health supplement) following the regulation. Supervise the registration of marketed product.
. Liaison with various distributors/consultants/DAV (Drug Administration of Vietnam) to facilitate the smooth registration activity
. Understand and share current updates in regulations/new guidelines/circulars published by DAV
. Evaluate and review registration dossiers for administration
. Keep track of registration status, submissions and registration timeline
. Closely follow up the status of application from the time of submission until getting approval
. Support Marketing team in applying advertisement licenses & detail aid material printing permits
. Monitor and disseminate information on changes to regulations affecting registration, manufacture, distribution and sale of Abbott products.
JOB REQUIREMENTS

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Work Experience: 3 years experience in Regulatory, prefer pharmaceutical MNC
CORE Skills Required:
Professional Skill
. Time management
. Persuasiveness
. Good in working arrangement, teamwork
. Honest, careful, patient, highly responsible

Behavioral / Leadership Skill: Apply Abbott Capabilities Framework
Language Skill: Vietnamese/ Ting Vit & English/Ting Anh
Computer Skill: MS office

MINIMUM EDUCATION REQUIRED
. Pharmacist/or Bachelor's degree/or Medical DoctorJOB FAMILY:
Regulatory OperationsDIVISION:
LOCATION:
Vietnam Hanoi : Handi Resco TowerADDITIONAL LOCATIONS:
WORK SHIFT:
StandardTRAVEL:
Not specifiedMEDICAL SURVEILLANCE:
Not ApplicableSIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter

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