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, to provide advice on regulatory matters to staff and customers and design RA strategy and lead cross functional meeting.

RESPONSIBILITIES

Independently manage registration of new products and variations to marketed products (mainly medical devices) to ensure regulatory approvals are achieved in accordance with company objectives.
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 corporate RA and NPI meetings.Design RA strategy and lead cross functional meetings.
Independently manage development projects, including early pipeline products, from RA perspective.
Communicate regulatory issues and evaluate the impact on the business to RA Director, senior management, Business Unit and GM where applicable.
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.
Lead, coach and develop RA team members to achieve departmental and business objectives.
Manage the performance of team members
Other regulatory projects and tasks assigned by RA Director.
University degree in Pharmacy, Pharmacology, Biology or related disciplines
About 8 years’ experience and in-depth knowledge of Taiwan Regulatory in Medical Device or Pharmaceutical Industry. New drug applications for NCE and clinical drug development knowledge will be an added advantage.
Strong communications and coordination skills
Proficiency in communicating strategic and tactical issues to management
Proven interpersonal skills
Excellent oral, written and good computer communication skills, including fluent English.

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