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Regulatory Affairs Officer

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  • Role: Senior Regulatory Affairs Associate
    Location: Dublin, Ireland (Occasional travel to the UK)
    Employment: Fixed term Contract
    Duration: 6 month
    Salary: €40,000 - €45,000 Pro Rata + Completion Bonus + Benefits
    Reference: J24616

    Regulatory Professionals are recruiting on behalf of a global leader within consumer health and over the counter products, we are seeking a Senior Regulatory Affairs Associate to operate out of the Dublin office for this renowned firm.

    About the company:
    World's leading consumer health and Hygiene Company. The firm has operations in over 60 countries, with headquarters in the UK, Singapore, Dubai and Amsterdam and sales covering every continent in almost 200 countries.
    Our clients health, hygiene and home portfolio is led by 19 global power brands, all of which you would be able to instantly recognise, likely because you use the products yourself.

    About the role:
    The successful regulatory Affairs Senior Associate will be directly involved in:
    - Coordinating and driving the completion of various applications submissions, including new MAAs, Variations, Renewals etc
    - Maintaining the SmPC, Product labelling and local regulatory database.
    - Review and approve promotional material.
    - Provide regulatory support to Global Regulatory, manufacturing sites and Supply.
    - Assist the Regulatory Affairs Manager in Ireland, to define the company's regulatory policies, guidelines and procedures as necessary.
    - Ensure on-going regulatory and product safety compliance of the company's existing product portfolio within the assigned Category segment(s) - submission of PSUR's/CCDS.
    - Assist/support/guide Junior team members & deputise for the Regulatory Manager as needed.
    - Assist in regulatory strategy and preparation of regulatory documents targeted at the Irish market
    - Execute the regulatory strategies that enable the delivery of a pipeline of product innovation to meet country requirements.

    About the candidate:
    - 2- 4 years Regulatory Experience within OTC, Consumer health or FMCG.
    - Understanding of the current Irish and European regulations, laws, guidelines and industry requirements.
    - Exceptional ability to manage workload and identify priority tasks to meet tight deadlines
    - Ability to build good relationships and challenge constructively and confidently
    - Eligible to work in Ireland and the UK.

    This is a brilliant opportunity for the right candidate to further their professional development with a well renowned industry leader.
    Opportunities to work for this company on a Fixed Term Contract basis don't come often, so if you would like to be considered, send through your call Asiel on at your earliest opportunity.

    Key words: Regulatory, Affairs, Officer, Senior, Associate, OTC, Consumer Health, FMCG, MAA, Variations, SmPC, CCDS, Dublin, Ireland, Relocation, Senior Regulatory Affairs Officer, Senior Regulatory Affairs Associate, Regulatory Associate, Regulatory Officer, Regulatory Contract, Bray, Drogheda, Lucan.


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