Mexico - Senior Leader - Regulatory Labeling - Freyr Solutions

    Freyr Solutions
    Freyr Solutions Mexico

    hace 3 días

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    Descripción

    About Freyr.

    Freyr Life Sciences. is a global leader in regulatory solutions and services within the life sciences industry. Freyr specializes in providing Regulatory Affairs, Pharmacovigilance, and Quality Assurance services. With a diverse team worldwide, we deliver efficient and compliant regulatory solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer healthcare sectors.

    Job Title: Senior Leader - Labeling

    Location: Mexico City, Mexico (Remote)

    Job Type: Permanent, Full-Time

    Position Objective

    The Senior Leader – Labeling is responsible for leading regional labeling operations across Local Operating Companies (LOCs), with a focus on enhancing process execution, compliance, and regulatory alignment. This role will work closely with LOC Regulatory Leads, Global Labeling, and cross-functional stakeholders to streamline labeling processes, support audits and inspections, drive continuous process improvement, and ensure alignment with global labeling systems and standards.

    Key Responsibilities

    1. Local Product Labeling Lifecycle Management

    Provide guidance to LOC Regulatory Leads on local labeling exceptions and safety variation submissions.

    Ensure accurate market label dependencies and timely submission/approval of deferral requests.

    Support Quality Events (Deviations) related to labeling, including CAPA development and effectiveness checks.

    2. Global Labeling Systems & Compliance Support

    Ensure LOCs maintain compliance with global labeling systems (e.g., MEDIVA RIM).

    Oversee lifecycle tracking and event management within labeling systems.

    Create simplified training resources (slides, FAQs, instruction manuals) for LOC teams.

    3. Audit & Inspection Readiness

    Support LOC Regulatory Leads during internal and external audits.

    Assist in audit presentation preparation and CAPA development in collaboration with Global Labeling Compliance.

    4. Stakeholder Collaboration

    Act as a liaison between Global Labeling and LOCs to facilitate two-way communication.

    Represent Global Labeling on cross-functional taskforces and initiatives.

    Coordinate with global regulatory operations including US/EU/Japan/China labeling teams.

    5. Escalation & Risk Management

    Escalate issues to Global Labeling management with mitigation strategies.

    Build and nurture strategic relationships across functions (Regulatory, Clinical, Safety, Medical Affairs, etc.) to support labeling processes.

    6. Labeling Process Training

    Collaborate with Compliance and Process Excellence teams to develop and deliver system/process training.

    Conduct live and virtual sessions for LOCs, ensuring current curricula and materials are in use.

    7. Continuous Improvement

    Solicit feedback from LOCs to identify areas for process optimization.

    Lead or support implementation of process revisions and enhancements to drive agility and compliance.

    8. Leadership & Cultural Stewardship

    Foster a culture of labeling process excellence and regulatory integrity.

    Promote collaboration and cross-functional engagement across regions and functions.

    Model adaptive leadership and embrace a growth mindset through feedback and continuous learning.

    Experience & Qualifications

    • Education
    • BSc degree required; BA accepted
    • Advanced scientific degree (MSc, PhD, PharmD) preferred
    • Experience
    • Minimum 10 years of pharmaceutical industry experience preferred
    • Minimum 6 years of direct labeling experience or combination of 5+ years in regulatory/related roles (compliance, training, etc.)
    • Technical Expertise
    • Deep knowledge of global (US, EU, Japan, China) and local labeling regulations
    • Familiarity with regulatory systems, Health Authority audits, and drug development lifecycle
    • Proficient in MEDIVA RIM or equivalent regulatory information management systems

    Core Competencies:

    Strategic Thinking

    • Ability to design and execute compliance-driven solutions for LOC labeling
    • Knowledge of managing single-country product labels (non-CCDS, generic, or divested products)

    Communication

    • Skilled in cross-functional communication and knowledge transfer
    • Able to simplify and communicate complex regulatory information effectively
    • Strong presentation and stakeholder management skills

    Analytical & Problem Solving

    • Advanced risk assessment and mitigation capabilities
    • Strong attention to detail and ability to lead investigations and process improvement initiatives

    Leadership

    • Effective in leading cross-functional teams and initiatives
    • Promotes diversity and inclusion
    • Drives accountability, feedback culture, and delivery of commitments

    Behavioral Attributes

    • Ethical decision-making aligned with company values
    • Proactive, adaptable, and flexible in a fast-paced global environment
    • Strong time management and prioritization skills
    • High attention to detail and quality of deliverables
    • Negotiation and consensus-building skills across stakeholders

    Why Join Us?

    Flexibility: Enjoy remote work with opportunities for client travel and industry engagement.

    Growth Opportunity: Be part of a fast-growing, global organization at the forefront of life sciences regulatory consulting.

    Innovation: Work with cross-functional teams delivering cutting-edge solutions to industry leaders.

    Equal Opportunity Employer

    Freyr Life Sciences. is an equal opportunity employer and values diversity at our company. All qualified applicants will receive consideration for employment without regard to race, religion, gender, sexual orientation, national origin, or disability status.

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