Regulatory Affairs Supervisor
Regulatory Affairs Supervisor
Posted on :
22-04-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities
- Manage 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 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.
Qualifications :
- University degree in Pharmacy Pharmacology Biology or related disciplines.
- Minimum 3 years experience and indepth knowledge of Taiwan Regulatory in new drug applications for NCE.
- Good communications and coordination skills.
- Proficiency in communicating strategic and tactical issues.
- Proven interpersonal skills.
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.
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No
Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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