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Regulatory Affairs - Taiwan

unlimited holidays - extra holidays - extra parental leave - long remote period allowed
Remote: 
Full Remote
Contract: 
Full time
Work from: 
Taiwan

Offer summary

Qualifications:

Knowledge in FDA submissions, Experience in dossier submissions, Familiarity with Corel Draw preferred, Minimum 24 months work experience.

Key responsabilities:

  • Ensure compliance with FDA and local laws
  • Handle dossiers submission and follow-up
  • Represent clients for registrations and audits
  • Maintain original documents and records
Genedrift logo
Genedrift Startup https://www.genedrift.com/
11 - 50 Employees
About Genedrift
Genedrift has been a trusted Regulatory and Pharmacovigilance provider across the entire business value chain. Whether pre or post market approved product safety, complaints management, medical inquiry support and post market surveillance through submission. Your organization's business requirements are unique and we excel at developing customized solutions leveraging our experience and team to automate and streamline business processes, aligning to our clients strategic objectives and providing a business solution that seamlessly integrates as a part of your organization, leading to customer satisfaction.
See more Genedrift offers

Job description

This is a remote position.

Ensuring necessary compliance with FDA, local laws/authorities
Evaluating dossiers for submissions, submission of dossiers both offline/online, and following up for status of dossiers/queries with FDA.
Responding to necessary queries, and meeting staff at FDA for resolution of queries.
Represent clients for all matters relating to registrations and audits and Communicate with customers within Taiwan for resolving queries / FDA issues.
Ensure the upkeep and safe custody of all original documents and records
Stay updated and continuously update internal documentation with reference to guidelines of FDA
Meet with clients and pitch them the services of the company for Taiwan and other markets.

​ Candidate Profile
Have knowledge and experience in applying for registrations, variation, and related activities with FDA.
Have experience in submission of dossiers for Drug, Cosmetics, etc with the FDA.
Will be additional if the candidate has knowledge of Corel Draw.
Female candidates preferred, and those with self-owned laptops.
Candidate should be able to comfortably work online and on computer.

Candidates' total experiences vs the total number of companies should not be less than 24 months at any place of work

The candidate will be working in the local office of the company.
Shall be based in Taipei.
If any travel outside of the city is required, it shall be done on the cost of the company.
The candidate will be required to own a laptop and comfortable internet connection, sufficient for video calls.​





Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Corel Photo-PaintDocument ManagementClient ServicesFDA RegulationsRegulatory Affairs
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