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    Manager, Regulatory Affairs - Roma, Italia - Adare Pharma Solutions

    Adare Pharma Solutions
    Adare Pharma Solutions Roma, Italia

    1 settimana fa

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    Descrizione


    Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world.

    Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success.

    With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery
    Join our mission at Adare
    What can Adare offer you?
    Health Insurance
    Pension Plan
    Benefits
    Performance-based bonus and Long-Term Incentive Plan
    We are seeking to hire a Manager, Regulatory Affairs to join our Regulatory Affairs Team ...

    JOB SUMMARY

    Manager, Regulatory Affairs is responsible for the regulatory aspects related to the product development, registration, and marketing of the Company's products under responsibility and for oversight of regulatory affairs at the European manufacturing facilities.

    This position is reporting to the Global Head of Regulatory Affairs and Pharmacovigilance/Exec. Director.

    Such support is provided through the identification, implementation, and management of regulatory strategies, preparation of regulatory documents for the filings, interactions with consultants and regulatory authorities.

    Other responsibilities are linked to the GMP area, through the definition and implementation of activities to support commercial products.

    The Manager, Regulatory Affairs hires, develops, and manages direct reports, is responsible for regulatory service providers, and manages departmental financial activities.

    ESSENTIAL DUTIES AND RESPONSIBILITIES

    Provides regulatory leadership in support of the development, registration with local and international health authorities, and maintenance of products under responsibility.

    Develops and implements short and long term regulatory strategies to achieve product development goals, product approval, and to support life cycle management projects for commercial products under responsibility.

    Ensures that all strategic and tactical activities are conducted in accordance with applicable regulations per local and international health authorities and working closely with the internal departments and across project teams.

    Ensures clear communication of project activities and progress in a timely manner.
    Oversees the planning and coordination of regulatory submissions and regulatory agency meetings.

    Manages and oversees the preparation and filing of regulatory submissions to support new product approvals and commercial products (including labeling).

    Authoring eCTD submission and managing regulatory change controls working with internal and external partners.
    Provide regulatory support to MAH for their applicable dossier file.
    Ensures submissions are complete, properly formatted, and comply with applicable regulatory requirements.
    Serves as a key contact with Health Authorities and facilitates communication between Health Authorities and the project team.
    Ensures timely and appropriate regulatory management of changes to products for CMC, clinical, and labeling.
    Manages contracts with regulatory consultants/vendors/partners in Europe.
    Supervises regulatory vendors.
    Manages the departmental budget definition process in Europe.
    Ensures compliance in departmental budget execution.
    Maintains a high level of professional expertise through familiarity with guidelines, scientific literature, and participation in training courses.
    Leads the selection process to hire direct reports and oversees the performance, training, and development of direct reports.

    Carries out his/her work in compliance with company procedures and in accordance with the provisions of the occupational health and safety management system and Good Manufacturing Practices.

    Works effectively under deadlines.

    Acts as the company's representative by showing respect and being an ambassador for the established beliefs and behaviors of the Company.

    Participates in the development and implementation of methods, procedures, and regulations necessary for the smooth operation of the business.
    Respects policies, procedures, and regulations in force in the company.
    Completes assigned tasks in a safe manner and in a constant state of alertness.
    Upholds Company policies, including the Ethics and Conduct Code.
    Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public.

    In particular, with regard to health and safety at work, besides the tasks provided for the "worker" pursuant to Legislative Decree 81/08, he/she contributes to the application of the health and safety at work management system in accordance with what is defined in the "MANUAL OF SAFETY AND SAFETY AT WORK" and in the relevant procedures.

    SUPERVISORY RESPONSIBILITY


    Regulatory Affairs Senior Specialist
    Regulatory Affairs Specialist.
    In particular, with regard to health and safety at work:
    Takes on the functions of "supervisor", for health and safety at work pursuant to Legislative Decree 81/08.

    Ensures the application of the health and safety management system at work within the scope of his function, in compliance with the provisions of the "MANUAL OF HEALTH AND SAFETY AT WORK" and the relevant procedures.

    Verifies that his/her staff implements the requirements of the relevant procedures.

    BS/MS degree from a 5-year accredited university or college; plus at least 5 to 8 years of related experience required in a similar role.

    PhD is preferred.
    Good knowledge and experience in the preparation and management of regulatory documentation in eCTD format and specifically quality part (eCTD Modules 2 & 3) for marketing authorization applications of pharmaceutical products and related lifecycle management (eg variations, renewals)

    Good knowledge of ICH / EU guidelines and European legislation on pharmaceuticals, with particular focus on the GMP/ quality area:
    knowledge of FDA guidelines and legislation will be considered a plus.

    Knowledge of the structure and content of marketing authorization dossier (CTD) of pharmaceutical products and of EU procedures (centralized, decentralized, mutual recognition, national).

    Good knowledge of GMP.
    Acquaintance with the basic principles of Project Management.
    Fluency in Italian (main language) and English (both spoken and written) is required.
    Excellent interpersonal written and oral communication skills
    Proficient in Microsoft Office including advanced skills in Excel.
    Ability to coordinate, contribute to, and work within a cross-functional team.
    Ability to work in a dynamic and fast-paced environment.
    Able to prioritize duties and manage multiple projects from start to finish with minimal supervision.
    Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
    Exceptional attention to detail and excellent organizational skills.
    Ability to accommodate up to 10% travel.
    Health Insurance
    Pension Plan
    Benefits
    Performance-based bonus and Long-Term Incentive Plan

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