Regulatory affairs specialist

hace 2 semanas

Ciudad de México, Ciudad de México ClarkeModet A tiempo completo

Clarke+Modet is a company specialized in Intellectual Property that manages regulatory processes within the healthcare sector. It carries out procedures before COFEPRIS related to medicines and medical devices, ensuring regulatory compliance for their commercialization in Mexico.

Education


• QFI – Industrial Pharmaceutical Chemist


• QFB – Pharmaceutical Biologist Chemist


• IF – Pharmaceutical Engineer


• International academic exchange program completed in an English-speaking country

Experience


• years in a similar role (biotechnological medicines, high-specialty products, allopathic drugs, generics, vaccines, and medical devices).

Responsibilities


• Plan and execute new registration projects, renewals, and modifications for Innovative, Biotechnological, Orphan, Generic Medicines, Vaccines, and Medical Devices.


• Update and review artwork texts with changes authorized by the Health Authority within the system.


• Prepare the regulatory documentation requested by the involved departments.


• Coordinate internal processes for advances, legalizations, reimbursements of expenses, and payment of professional fees related to the Regulatory Affairs area.

Knowledge


• Preparation of dossiers for new registrations, renewals, and modifications to registration conditions for biotechnological, allopathic, generic medicines, and vaccines.


• Knowledge and handling of the General Health Law (LGS), the Regulation of Health Supplies, and Official Mexican Standards applicable to Sanitary Regulation.


• Technical English, C1 level.

We Offer


• Hybrid work schedule, Monday to Friday.


• Salary open to negotiation according to experience.


• Benefits above those required by law starting from the third month.

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