Regulatory Affairs Executive

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. As Senior Talent Acquisition Manager you will play a critical role in setting the strategy and leading a team of internal recruiters and external partnerships to effectively attract hire and maintain a continuous pipeline of well-qualified talent.

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.

The primary scope of the Regulatory Affairs Executive role is including:

• Execution: Ensure the implementation of RA strategies according to the guidance of the RA director/manager in preparing dossier and registering with the Ministry of Health to obtain and maintain product licenses; product advertising certification; internal review promotional material to ensure compliance.
• External engagement with Health authority: follows up with Health authority to ensure product registration smoothly got the product licenses on time with key claims protected gather regulatory intelligence.
• Cross-functional support: provide information related to regulation and product to support cross functions team perform RA team administrative tasks.

• Preparing dossier for Products registration product advertising registration

• Internal Review Promotion Materials

• Follows up with Health Authority

• Negotiation with Health Authority

• Gather regulatory intelligence.

• Provide product technical information regulation to support other functions

• Act as regulatory consultant to other functions

  Perform administrative task

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED

• At least 1 years (Years of experience in overall Nutrition/ Pharmacy/ Medicine industry or specific in regulatory affairs)
• Good technical knowledge on nutrition or pharmacy or medicine.
• Communication skill: Clearly conveying information and ideas to Health authority to engages and helps them understand and accept companys submission.
• Follow-up: Closely monitoring the product registration process and timely report to RA director/manager respond to Health authoritys request under instruction from RA director/manager
• Negotiation skill: Effectively exploring alternatives and positions to reach outcomes that gain the acceptance for product submission
• Adaptability Initiative Innovation Integrity Teamwork
• English B1 (Reading Writing Listening Speaking)

The base pay for this position is

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

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