Regulatory Affairs Coordinator

hace 1 semana

Colonia Polanco, México Fenixfarma Mexico City, Mexico A tiempo completo

Fenixfarma is seeking a Regulatory Affairs Coordinator to join our team in Polanco, Mexico City. This full-time, on-site position and is available for immediate start. The Regulatory Affairs Coordinator will be responsible for preparing and maintaining regulatory documentation, ensuring compliance with local and international regulatory requirements, coordinating regulatory submissions, and collaborating with cross-functional teams to support regulatory needs. Experience in assembling drug product and medical device dossiers is essential for this role; experience with government tenders is a plus.**Responsibilities**:Prepare and maintain regulatory documentation, including assembling drug product and medical device dossiersEnsure compliance with local and international regulatory requirementsCoordinate regulatory submissions to relevant health authoritiesCollaborate with cross-functional teams to support regulatory needs**Qualifications**:Expertise in regulatory documentation, submissions, and compliance requirementsProven experience in regulatory affairsStrong attention to detail and organizational skillsExcellent written and verbal communication skills in Spanish and EnglishBachelor’s degree in Pharmacy, Biology, Chemistry, or a related fieldAbility to work independently and collaborativelyExperience assembling drug product and medical device dossiers (essential)Experience with government tenders (a plus)Pharmaceutical industry experience (a plus)Pay: $10,000.00 - $15,000.00 per month**Experience**:- Regulatory Affairs : 1 year (preferred)**Language**:- English (preferred)Work Location: In personExpected Start Date: 11/05/2025

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