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Regulatory Affairs - Pakistan

unlimited holidays - extra holidays - extra parental leave - long remote period allowed
Remote: 
Full Remote
Contract: 
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Offer summary

Qualifications:

Experience with DRAP registrations and submissions, Knowledge of FDA submission processes.

Key responsabilities:

  • Ensure compliance with local regulations and DRAP
  • Handle submissions, queries, and document management
  • Represent clients and communicate internally & externally
Genedrift logo
Genedrift Startup https://www.genedrift.com/
11 - 50 Employees
See more Genedrift offers

Job description

This is a remote position.

Ensuring necessary compliance with DRAP, local laws/authorities
Evaluating dossiers for submissions, submission of dossiers both offline/online, and following up for status of dossiers/queries with DRAP.
Responding to necessary queries, and meeting staff at DRAP for resolution of queries.
Represent clients for all matters relating to registrations and audits and Communicate with customers within Pakistan for resolving queries / DRAP 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 DRAP
Meet with clients and pitch them the services of the company for Pakistan and other markets.

Candidate Profile
Have knowledge and experience of applying registrations, variation, and related activities with DRAP.
Have experience in submission of dossiers for Drugs, Cosmetics, etc with 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 the computer.

Candidate's 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 Rep Office of the company.
Shall be based at Hanoi.
If any travel outside of the city is required, shall be done at 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.

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