REGULATORY AFFAIRS MANAGER SR.

INTERNATIONAL LABORATORY

Requirements:

Bachelor's degree or engineering degree in pharmaceutical biology, industrial pharmaceutical chemistry, chemistry, biochemistry, or a related field.

Minimum of 15 years' experience in the regulatory field with expertise in local and international regulatory standards for medicines and controlled products

Knowledge of good manufacturing practices and regulatory documentation.

Presential Work on the suth of the City

Advanced English (written and spoken)

Activities:

Development of strategies to obtain and maintain product approvals from regulatory authorities, ensuring the company's compliance with all local and international regulations.

Preparation and monitoring of regulatory documentation.

Relations with regulatory authorities .

Responsible for Pharmacovigilance

Compliance with internal and external audits.

Team coordination for regulatory project management.

Dossiers submissions for registration, re-registration, amendments, approval and also follow-up of these cases until their conclusion.

Knowledge for NOM´s (257, 059, etc) control substances, as well as the legal framework of the Mexican regulations pharmacopoeia, FEUM, RIS, International Health Regulation and COFEPRIS. (knowledge in manufacturing processes needed only for review and assemblimg a dossier)

Goal oriented person needed

Attention to detail

Constantly follow-up for medicines needed

We offer:

Direct hiring, base salary, statutory and higher benefits, among others.

Interested candidates please apply here. Attach your updated CV.