Regulatory Affairs Specialist

Regulatory Affairs Specialist

Job description:
Full time On-Site, 9:00AM to 6:00PM in Polanco CDMX, Mexico

Immediate job!

Chemist/ Biologist and also Pharmacist Diploma.

Experience in Dossier preparation for Drug products: take care of the preparation of your dossier. Viewing, checking, preparing for submission to COFEPRIS, Printing, submitting.

At least 1 year experience is drug products dossier preparation for submission: preparations of all legal documents, translations, label artwork...and drug product registration at COFEPRIS.
Advantages of knowledge in online submission of dossier on DIGIPRIS.

High communication skills in English & Spanish

Ability to work under pressure and communicate in English with companies/manufacturer and regulatory authorities by ensuring that products are manufactured, tested, and distributed in compliance with appropriate legislation.

Help you find the right classification for your product.

Pharmacovigilance and technovigilance: Risk management plan for New molecule; submit to the regulatory authority. Support the plan and all the corresponding reports that are needed.

Patent Expiration: prove expiration date of patent.

Forecasts: Research market & prepare forecasts for drug products based on IMSS tender reports.

Experience with Google Suite & Microsoft Office.

Loyal, Diligent, smart, independent, can work under pressure.
Monthly income about thousand US dollars.

Join our start up team and grow with us!

Work Location: In person

Expected Start Date: 10/11/2024