Remote Regulatory Affairs Consultant – Pharma Expert

Placements24; San Luis Potosí; Hybrid; MXN 1,671,000 - 2,228,000; Full time

Job summary

Placements24 is seeking an experienced Farmacéutico Consultor en Regulatorio to provide expert guidance to pharmaceutical companies. This fully remote contract role offers flexibility and exposure to diverse regulatory projects, including NDAs, ANDAs, and variations, with emphasis on COFEPRIS and international regulations.

You will advise clients on navigating regulatory landscapes, preparing submission dossiers, and ensuring compliance while working remotely with international clients.

Qualifications

• Pharm.D. or an equivalent advanced degree.
• At least 10 years of progressive experience in pharmaceutical regulatory affairs.
• Experience preparing and submitting regulatory dossiers to major health authorities.
• Knowledge of COFEPRIS and international regulations (FDA, EMA).
• Remote, client-facing role with ability to manage multiple projects.

Responsibilities

• Provide strategic regulatory advice for product registration and lifecycle management.
• Prepare and review regulatory submission dossiers for health authorities.
• Interpret and apply regulatory guidelines for pharmaceutical products.
• Liaise with regulatory agencies on behalf of clients to facilitate approvals.
• Develop regulatory strategies aligned with client objectives.
• Manage multiple client projects remotely with timely delivery.

Skills

Regulatory affairs

Strategic thinking

Project management

Communication skills

Education

Pharm.D.

Job description

Placements24 is seeking an experienced Farmacéutico Consultor en Regulatorio to provide expert guidance to pharmaceutical companies. This fully remote contract role offers flexibility and exposure to diverse regulatory projects, including NDAs, ANDAs, and variations, with emphasis on COFEPRIS and international regulations.

You will advise clients on navigating regulatory landscapes, preparing submission dossiers, and ensuring compliance while working remotely with international clients.