Description

ICompany Description

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.

Job Description

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.

Qualifications

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.

Additional Information

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.htmlI