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Site Readiness and Regulatory Specialist I (Taiwan)
Taipei, Taiwan · On-site
Entry level
Job Overview: Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/I…
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Full-time
bachelor degree
Posted 28d ago
~40 hrs/week
Responsibilities
Manage the preparation and submission of regulatory documents to obtain and maintain marketing approvals for medical devices and pharmaceuticals in Taiwan. Lead cross-functional meetings to design RA strategies and oversee the development of early pipeline products.
Requirements
Requires a university degree in Pharmacy, Pharmacology, Biology, or a related field with approximately 8 years of experience in Taiwan regulatory affairs. Must possess strong communication skills and proficiency in English.
Full job description
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Job Description
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 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.
Qualifications
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.
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.
Allergan is now part of 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 LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
Health CareBiopharmaEducationBiotechnologyMedicalUniversitiesPharmaceutical
How many Legal jobs are open in Taipei, Taiwan right now?
There are currently 87 open legal positions in Taipei, Taiwan listed on Clera. New openings are added daily as companies post roles.
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