Senior Regulatory Affairs Executive Abbott Pharmaceuticals

JOB DESCRIPTION:

ABOUT ABBOTT

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and products in diagnostics medical devices nutritional and branded generic medicines. Our 114000 colleagues serve people in more than 160 countries.

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 THE ROLE

• Execute regulatory activities including dossier preparation submission and follow-up for product registration and lifecycle management in Vietnam.

• Ensure compliance with evolving local regulations and supports strategic product launches through timely and accurate regulatory execution.

MAIN RESPONSIBILITIES

• Be responsible for registration of all products manufactured in CFR Chile independently in dossier preparation in communication with internal stakeholders including EM APAC regulatory to order follow up back and ford conversations in getting the dossier on-time with high quality standard of the documents in managing relevant regulatory systems i.e. CMC for technical documents CSCC for Legal documents Agile for Artwork development RINR for regulation impact analysis Darius for tracking and archiving regulatory data

• Independently contact with external KOLs at department levels i.e. DAV for registration status and accelerate the approval timeline with Hanoi Medical University Hanoi Pharmaceutical University National Institute of Drug Quality Control (NIDQC) to explain and get support get insights to ensure the deficiency submission can be passed and shorten the processes.

• Directly handle registration work of Influvac with 2 major variations for seasonal strain update NH and SH annually. The 1st launch to the market is the one of key success factor for Influvac business so the urgency high dossier quality good relationship network well understand KOLs insights and process of different Health Authorities are critical requirements.

• Support new NPI project called EMPA with 2 SKUs which required to submit within 2025 and accelerate approval to support for the business.

• Support other functions to provide tender documents promotional materials for responsible products.

• Support RAD in working with Pharma Associations (Eurocharm US ABC) i.e. consolidate comments from members for new regulations draft take minutes of meetings follow up DAV on the comment submission organize meetings

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED

Work Experience:

• Knowledge of regulations and standards.

• At least 3 years relevant experience in regulatory affairs.

Professional skills:

• Communication

• Customer focus

• Follow-up

• Negotiation

• Problem solving and decision making

Behavioral skills:

• Apply Abbott Capabilities Framework

Language skills:

• Vietnamese/ Tiếng Việt

• English/Tiếng Anh

MINIMUM EDUCATION REQUIRED

• Bachelors Degree in pharmacy or Registered Pharmacist in Vietnam

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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