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East Kilbride

    Regulatory Affairs - East Kilbride, South Lanarkshire, United Kingdom - Real

    Real
    Real East Kilbride, South Lanarkshire, United Kingdom

    1 week ago

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    Description

    Our client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market.

    A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products they have operations in 12 major markets, with marketing and distribution agreements in more than 130 countries.


    Driven by scientific research, technology, and keeping a pulse on consumers' aspirations, the global teams are dedicated to providing effective solutions for customer needs through developing high quality, innovative new products.

    To ensure continuity they are looking to add a Head of Regulatory Affairs to the team. Oversee the Regulatory Affairs (RA) activities for all products in all territories to support the manufacture, importation, sale and supply of medicines, medical devices, cosmetics, and other product categories
    Formulate strategy and actions to assure successful initiation, management and maintenance of regulatory authorisations, through liaison with Competent Authorities, and contractors
    The Head of Regulatory Affairs will provide a "one stop shop" for regulatory advice and support, as well as coordination of training for key areas of the business in regulatory requirements
    Assure and maintain the compliance of the business with regulatory requirements
    Assure that the Regulatory Affairs team has the necessary training and support
    Evaluation of workload, quality and metrics through regular review and reporting of findings
    The Head of Regulatory Affairs will assure that all product registrations and certifications, including facility registrations, are maintained and compliant across territories
    Collaborate with functions on change management and compliance
    Collaborate with NPD to develop innovative claims and formulations that will optimise routes to market
    Provide sound regulatory strategy and advice to Senior ManagementDeliverables:

    Formulate RA strategy and complete regulatory activities to agreed schedules
    Oversee and/or contribute to regulatory submissions prepared by the regulatory team
    The Head of Regulatory Affairs will mentor and encourage sharing of knowledge with the regulatory team to help build, establish, and maintain a strong regulatory presence
    Establish and maintain regulatory intelligence to best support the business
    Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance
    Track record in pharmaceutical regulatory affairs and ideally medical device legislation (not a deal breaker)
    Regulatory exposure to environments in local and international territories
    Working in or with manufacturing, quality assurance, pharmacovigilance, marketing and commercial

    Ability to travel as requiredQualifications:
    Regulatory experience in Life Sciences (e.g. Although the position is based in Scotland there is some hybrid working on offer for those that can't make it to site daily - this can be discussed on a case by case basis

    Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone number removed) England and Wales
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