Job Information
Abbott Senior Regulatory Affairs Manager in New Taipei City, China
Primary Job Function
To manage the regulatory aspects of Core Diagnostics NPIs and on-market products updates to comply with local Government Regulatory and Statutory legislation in alignment with department goals.
To liaise with internal and external stakeholders.
Monitor changes in the regulatory environment to formulate the most appropriate company response to facilitate new and support on going registration activities.
To ensure all Core Diagnostics Departments are in compliance with the local regulatory requirements, specific to importation and supply of products to the local market.
Core Job Responsibilities
Regulatory
Focus on Regulatory, Registration and Reimbursement strategies for new and currently registered products. Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory outcomes to support Marketing goals.
Focus on ensuring all products requiring local clinical/performance evaluations, at various local institutions, including designated testing laboratories and hospitals, are done and completed within the timelines required for NPI launches or renewals, ensuring no disruption to commercialization.
Maintain necessary contacts with all Regulatory and Statutory bodies, government representatives and industry associations.
Partnering with local regulatory agencies and industry associations on new and changing regulations in the country.
Monitor changes in the regulatory environment to formulate the most appropriate company response to facilitate new and support on going registration activities.
Be the key liaison point for all regulatory enquires across the organisation.
Support all aspects of auditing and accreditation requests.
Support, and assist by providing the regulatory specific documentations required for Commercial Tenders.
Ensure all reportable serious or adverse incidents are filed in a timely manner, according to local regulatory requirements.
Review and approval of Promotional Materials in compliance with regulatory requirements.
Manage and Maintain appropriate Licenses and Import/Export permits.
On a timely basis, prepare or arrange for preparation, the Regulatory budgets, reports and forecasts.
Supervisory/Management Responsibilities
Effective management of the Company’s regulatory affairs change strategy
To work in a collaborative environment with functional departments, i.e. Marketing, Logistics etc. to ensure regulatory compliance with regulations and other relevant Regulatory Agencies.
Ensure that RA team members are skilled and kept up to date with changes to regulations and standards and to advise local and global colleagues of the impacts of such changes.
Position Accountability / Scope
Reporting to APAC RA Associate Director
Responsible for maintaining RA Department and submissions budget
Minimum Education
Bachelor Science degree
Detailed knowledge of various regulatory agencies in country
Minimum Experience/Training Required
Minimum 7 years regulatory experience within the diagnostics industry
Working experience in regulatory agency is a plus
Minimum Skills Required
Proven ability to lead a team
Influence Skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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