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    Head of Regulatory Affairs - East Kilbride, United Kingdom - Real

    Real
    Real East Kilbride, United Kingdom

    Found in: Click to Hired UK C2 - 5 days ago

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    Permanent, Full time
    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 globally.


    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. The position will report to a Director and manage a small team of Managers and their teams.


    Position:
    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
    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
    Develop, maintain and assure interaction of the RA team with suitable systems to support progression and complianceDuties:

    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
    Support of the introduction of new products and registrations
    Assure that all product registrations and certifications, including facility registrations, are maintained and compliant across territories
    Collaborate with all functional categories within the business
    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
    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
    Ensure monthly report is delivered in a timely mannerSkills:

    Written, oral and presenting skills
    Lead and work in a team with a sense of responsibility
    Track record in pharmaceutical regulatory affairs and medical device legislation
    Regulatory environment in local and international territories
    Working in or with manufacturing, quality assurance, (pharmacovigilance), marketing and commercial
    Interfacing with Competent Authorities globally

    Ability to travel as requiredQualifications:
    Either Degree in Life Science or track record in a similar position
    Member of TOPRA is desirable
    Regulatory experience in Life Sciences (e.g. Pharma, Biotech, Med Dev etc.)Although the position is based in Scotland there is some hybrid working on offer for those that can make it to site 2-3 days a week.

    To find out more about Real please visit

    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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