Regulatory Affairs Specialist

Regulatory Affairs SpecialistJob description:Full time On-Site, 9:00AM to 6:00PM in Polanco CDMX, MexicoImmediate 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 & SpanishAbility 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 personExpected Start Date: 10/11/2024