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  • Posted: Jan 12, 2022
    Deadline: Not specified
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  • SANOFI IS A GLOBAL HEALTHCARE LEADER FOCUSED ON PATIENTS’ NEEDS engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.
    Read more about this company

     

    Regulatory Affairs Associate

    Job Requisition ID: R2626732
    Grade: N2-1
    Job type: Full time
    Reports to: Country Regulatory Affairs Head
    Department: Regulatory Affairs

    Role Responsibilities

    • Coordinate dossier and briefing package preparations according to the plans (new registration and maintenance) and monitoring dossiers up to implementation.
    • Ensures optimal support to key stakeholders to deliver on-time high quality dossiers in compliance with Health Authority requirements.
    • Liaise with HA contact person; organizing and preparing HA meeting and attending as appropriate.
    • Manage the maintenance of a portfolio of products.
    • Accountable for keeping the databases updated on a timely basis for portfolio he / she is in charge of.
    • Provide support and communicating information on products to other functions (approvals, ...)
    • Review and validate at country level promotional material with Marketing and Medical in line with Global strategies and policies.
    • In liaison with his / her manager, can be involved in activities such as shortages, DHPC, B / R reevaluation, etc.
    • Support the consolidation and provision of regulatory expertise and giving input about requirements and needs.
    • Follow regulatory changes

    Working Relationships

    • Internal: Supply Chain; Pharmacovigilance; Business Units
    • External: NAFDAC; Distribution Centre and other relevant stakeholders

    Requirements
    Education and Experience:

    • Education: Master's Degree in Pharmacist, Physician, Veterinarian or preferably Life Sciences
    • Related Experience: Minimum of 1-3 years’ experience  in similar position  in different types of registrations, preferably in  multinational organization.

    Requirements - Professional Knowledge and Skills:

    • Negotiation & communication skills
    • Organization skills and high accuracy in documentation
    • High sense of urgency
    • Priority setting and management
    • Knowledge of new decrees & guidelines
    • Multitasker
    • Awareness and adherence to company internal SOPs & compliance standards
    • Promptness in respond to authorities requirements and prompt in deliverables
    • Analytical skills
    • Ability to alert hierarchy in case of specific situation impacting his/her work environment
    • Problem solving skills
    • Presentation skills
    • Interpersonal skills
    • An understanding and appreciation of relevant legal, scientific and manufacturing area.

    Method of Application

    Interested and qualified? Go to Sanofi on sanofi.wd3.myworkdayjobs.com to apply

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