Regulatory Affairs Supervisor

• Manage registration of new products and variations to marketed products to ensure regulatory approvals are achieved in accordance with company objectives.
• Ensure new product registrations and approval maintenance is conducted in a timely manner according to the registration plan, with guidance from RA manager where required.
• Coordinate responses to deficiency letters and other requests for data from regulatory authorities for products and ensure it meets agreed or required timelines.
• Liaise with officials of government agencies to facilitate evaluation processes and respond to requests for data in agreed timelines.
• Update product labeling in a timely manner based on the update of the product labeling from headquarters.
• Review labeling and product information to ensure compliance with relevant regulations and codes.
• Generate registration plans and provide regular status reports.Report progress and status to manager and management as required including to corporate RA and NPI meetings.
• Communicate regulatory issues and evaluate the impact on the business to RA director, senior management and Business Unit, and to GM where applicable, under the supervision of RA manager.
• Maintain good knowledge of relevant corporate policies and local regulations and ensure compliance.
• Keep abreast of regulatory changes and evaluate the impacts on the business and communicate changes in a timely manner to related parties and management.
• Update RA SOPs when regulations and processes are updated and review them to ensure they are within the validity timeframe.
• Participate in RA process and streamline processes to increase productivity.
• Other regulatory projects and tasks assigned by RA Director/Senior Manager/Manager/Associate Manager.

Qualifications

• University degree in Pharmacy, Pharmacology, Biology or related disciplines
• Minimum 3 years' experience and in-depth knowledge of Taiwan Regulatory in new drug applications for NCE
• Good communications and coordination skills
• Strategic and 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