Company 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 (https://www.tiktok.com/@abbvie) . 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.html