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

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