Regulatory Affairs Manager - Mexico City - confidential

    confidential
    confidential Mexico City

    hace 11 horas

    Farmacéutico / Biotecnología
    Descripción

    Regulatory Affairs Manager

    Location: Guadalajara, Jalisco / Mexico City

    Industry: Pharmaceutical

    Seniority Level: Manager

    Modality: Hybrid

    Position Overview:

    We are seeking an experienced Regulatory Affairs Manager to lead the development and execution of regulatory strategies ensuring the full compliance of our product portfolio—nationally and internationally. This includes bioequivalent and bioavailability drugs, medical devices, controlled substances, and imported products.

    You will act as the key liaison with health authorities such as COFEPRIS, FDA, EMA, as well as international customs and regulatory entities, facilitating agile, safe, and legally sound access of products to the market.

    Key Responsibilities:

    • Design and implement regulatory strategies for the registration, importation, and lifecycle management of pharmaceutical products and medical devices.
    • Coordinate the preparation and submission of dossiers for new registrations, renewals, modifications, and controlled product procedures before COFEPRIS and other agencies.
    • Manage prior import permits, including those for controlled substances and regulated raw materials.
    • Ensure compliance with Mexican Official Standards (NOMs), ICH guidelines, and other applicable international regulations.
    • Oversee documentation processes, including import notices, labeling, certificates of analysis, and free sale certificates.
    • Collaborate closely with quality, logistics, and customs teams to guarantee efficient product flow and regulatory alignment.
    • Lead regulatory audits, manage responses, and ensure timely implementation of corrective actions.
    • Develop and maintain the Quality Management System Manual, ensuring compliance with Good Manufacturing, Documentation, Storage, and Distribution Practices.
    • Represent the company before regulatory bodies and participate in sectoral forums or working groups.
    • Maintain up-to-date regulatory databases and lead training efforts for the internal regulatory team.

    Required Profile:

    Education:

    • Bachelor's degree in Pharmaceutical Chemistry, Biotechnology, Pharmacy, or related fields.
    • Preferred: Master's or specialization in Regulatory Affairs, Foreign Trade, or Health Legislation.

    Experience:

    • Minimum 5–7 years in regulatory affairs within the pharmaceutical industry, handling medicines, controlled substances, and medical devices.
    • Proven expertise in import procedures, prior permits, and customs regulation.
    • Experience managing regulatory platforms (Digipris, VUCEM, CECI).
    • Solid relationships with COFEPRIS, SSA, Customs, and international agencies.

    Technical Knowledge:

    • Comprehensive understanding of national and international health regulations (NOMs, ICH, FDA, EMA, WHO).
    • Familiarity with foreign trade laws, COFEPRIS regulations, and applicable treaties.
    • Regulatory handling of controlled substances (psychotropics, narcotics).
    • Knowledge in clinical studies and bioavailability/bioequivalence documentation.
    • Advanced English is essential; a second language is a strong asset.

    Core Competencies:

    • Strong technical and regulatory expertise.
    • Leadership, strategic thinking, and decisive execution.
    • Clear and assertive communication skills, both internally and with authorities.
    • Risk management and problem-solving in complex regulatory scenarios.
    • High standards of organization, precision, and ethical responsibility.

    Why Join Us?

    We offer a competitive compensation package and industry-leading benefits in the pharmaceutical sector. Join a mission-driven team shaping regulatory excellence on a global scale.

    Apply today and make an impact

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