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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Manager, Regulatory Affairs

Taipei, Taiwan Req ID 2200858 Category Regulatory Affairs Division AbbVie

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 researches, product launches, business development so as to assist in achieving business growth and full compliance with legal requirements for pharmacovigilance regarding regulatory affairs relevant responsibilities. 

POSITION PRIMARY FUNCTION
The position is to handle the 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


MAJOR DUTIES AND RESPONSIBILITIES:

  • Independently manage the registration of new products and variations to marketed products (including medical devices) 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.
  • Report progress and status to manager and superior management as required including to corporate RA and NPI meetings.
  • Develop a checklist and streamline processes to increase productivity.
  • 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.
  • Develop sound credibility and support with key targeted government, regulatory and enforcement officials. 
  • Review labeling, over-labeling, product information to ensure compliance with relevant regulations and codes. Update product labeling in a timely manner based on the update of the product labeling from headquarters.
  • Lead and communicate regulatory issues and important changes and evaluate the impact on the business to RA director, senior management and the Business Unit.
  • Provide regular legal assessments of the commercial implications of proposed national regulation & legislation. Discuss internally and devise/implement strategies to protect and advance the company’s interests
  • Design RA strategy and lead cross-functional meeting
  • 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.
  • Take an active role in assigned projects on an individual and team basis in support of specific departmental and corporate objectives.
  • Update RA SOPs when regulations and processes are updated and review them to ensure they are within the validity timeframe. 
  • Other regulatory projects and tasks assigned by RA Director
Qualifications:

QUALIFICATIONS

  •   University degree in Pharmacy, Pharmacology, Biology or related disciplines
  • Minimum 10 years’ experience and in-depth knowledge of Taiwan Regulatory in new drug applications for NCEs, Medical Device, clinical drug development and clinical trial applications
  • 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. 
  • Sound analytical, conceptual and strategic thinking skills.
  • Demonstrated ability to consistently deliver against time-sensitive deadlines in the midst of conflicting demands.
  • Commitment to achieve excellence with a strong work ethic and results orientation.
  • Ability to work independently, analyze complex problems and take initiatives.
  • Ability to interact effectively at all levels with sensitivity to cultural diversity.
  • Ability to function as an effective team member.   
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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