Offer summary

Qualifications:

5+ years of experience in regulatory affairs, particularly with FDA compliance., Knowledge and experience in applying for registrations and submissions for drugs and cosmetics., Ability to work online and manage documentation effectively., Preferred candidates are female and should own a laptop with a reliable internet connection..

Key responsabilities:

Ensure compliance with FDA and local laws regarding submissions and registrations.

Evaluate and submit dossiers, both online and offline, and follow up on their status.

Communicate with clients and resolve queries related to FDA issues and registrations.

Maintain original documents and internal documentation in accordance with FDA guidelines.

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.

Salary:

NTD 270000 to 340000