AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

This role will report into RA manager. 

Department Function/Objectives:

• Obtain and maintain marketing approvals for AbbVie products in Taiwan.
• Ensure full compliance with local regulatory and company requirements.
• Support clinical research, product launches, business development for growth and compliance.

Primary Function/Objective:

• Prepare regulatory submissions to obtain and maintain product marketing approvals.
• Advise staff and customers on regulatory matters.

Core Job Responsibilities:

• Manage registration of new products and variations for timely regulatory approvals aligned with company goals.
• Ensure product registrations and maintenance are timely, following the registration plan and manager guidance.
• Coordinate responses to deficiency letters and data requests from authorities within set timelines.
• Liaise with government agency officials to facilitate evaluations and respond to data requests.
• Update product labeling in line with headquarters’ updates and ensure timely review for regulatory compliance.
• Review labeling and product information for regulatory accuracy.
• Create registration plans and provide regular status reports.
• Report progress to managers, including at corporate RA and NPI meetings.
• Communicate regulatory issues and impacts to RA director, senior management, Business Unit, and GM (with RA manager’s supervision).
• Maintain knowledge of corporate policies and regulations, ensuring all compliance requirements are met.
• Keep up-to-date with regulatory changes, assess business impact, and communicate to stakeholders in a timely manner.
• Update and review RA SOPs when regulations or processes change.
• Participate in and optimize RA processes for efficiency.
• Handle other regulatory-related projects or tasks as assigned.

Preferred Qualifications:

• University degree in Pharmacy, Pharmacology, Biology, or related disciplines.
• Minimum 3 years’ experience with in-depth knowledge of Taiwan regulations for new drug applications (NCE).
• Strong communication and coordination skills.
• Strategic, analytical thinking.
• Proficiency in communicating strategic and tactical issues.
• Proven interpersonal skills.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html