Regulatory Affairs Manager - Taguig - PHARMACEUTICAL

    PHARMACEUTICAL
    PHARMACEUTICAL Taguig

    1 araw ang nakalipas

    Pharmaceutical / Bio-tech
    Paglalarawan

    Job Purpose

    • Locally manage the overall Regulatory Affairs and Pharmacovigilance functions. Liaise and negotiate with FDA on Regulatory issues.
    • Ensure that the Quality Management System (QMS) is effectively executed, monitored and adhered to within the department and company.
    • Manages the regulatory, quality and compliance aspects of partnering activities, ensuring smooth transitions and compliance for in-licensed and out-licensed products.

    Major Accountabilities

    REGULATORY

    • Provides regulatory expertise to the business
    • Serves as the chief negotiator with government agencies during the review and approval process
    • Leads and manages the entire registration process and other FDA related activities. Strategically plans regulatory action to ascertain product approval
    • Accountable for the maintenance of all licenses, certificates, permits which enable us to market and distribute products
    • Keeps abreast with the new and changing legislation in the country .
    • Advises management of the impact of newly finalized and/or proposed regulations, guidelines and standards of FDA and other governing body
    • Provides regulatory input to lifecycle planning of a product
    • Ensures changes with impact on regulatory, quality and safety are assessed, reviewed, submitted and approved as necessary prior to implementation
    • Manages the creation of Risk Management Plan for locally acquired products
    • Ensures that regulatory systems, processes, tools and methods to ensure good regulatory practices, regulatory submissions, documentation practices are utilized and effectively carried out
    • Builds and maintains a credible relationship with the regulatory authorities
    • Involved in the review and approval of publicly disseminated information to minimize regulatory exposure and protect company interest

    PHARMACOVIGILANCE

    • Functions as the Qualified Person in Pharmacovigilance (QPPV)
    • Ensures aggregate reporting of periodic reports such as PSURs, PBRERs, DSR and other clinical reports to FDA
    • Ensures data management
    • Ensures all employees are trained on the required Pharmacovigilance activities such as handling adverse events, product complaints and medical inquiries
    • Develops, implements and manage procedures and systems to track and manage Pharmacovigilance related events

    OTHERS

    • Managing Regulatory Affairs personnel and projects ensuring timelines and regulatory compliance are met
    • Mentors and develops Regulatory and Pharmacovigilance personnel within the department
    • Implements & maintains Performance Management and Development Scheme
    • Sets and manages annual budget for the Regulatory and Pharma Affairs
    • Committee member on Data Privacy Project
    • Act as the Project Technical Manager for Regional Projects
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