DEPARTMENT FUNCTION/OBJECTIVES
The Regulatory Affairs Department obtains and maintains marketing approvals of responsible Abbvie products in Taiwan. It ensures full local regulatory and company compliance, and provides regulatory expertise to support clinical research, product launches, business development so as to assist achieving business growth and full compliance with legal requirements for pharmacovigilance regarding regulatory affairs relevant responsibilities.
PRIMARY FUNCTION/OBJECTIVE
The position is to handle preparation of regulatory submissions in order to obtain and maintain marketing approvals of company products, and to provide advice on regulatory matters to staff and customers.
CORE JOB RESPONSIBILITIES
- 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.