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    Risk and Governance Executive - United Kingdom - Pharmanovia

    Pharmanovia
    Pharmanovia United Kingdom

    2 weeks ago

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    Description
    Basildon, Essex (hybrid: 3 days office, 2 days home)

    Salary:
    Competitive + Benefits + Bonus
    If you are an agile, committed, and innovative regulatory affairs professional in the pharmaceuticals sphere then we want to hear from you
    Join us to help improve peoples' lives and make healthcare better for everyone

    Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets.

    Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.
    We value our heritage and foster an entrepreneurial spirit.
    We reinvest in our future – in our products, our brands, and our people.
    We give back to our communities.

    Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world.

    Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities.

    A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.Pharmanovia's therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

    Reporting to Director, Regulatory Affairs, you will be a key member of the team which is responsible for submission of regulatory safety updates including SmPC, PIL reviews as well as PSUR/PBERs and RMPs.

    Our Regulatory Affairs Department has an ethos of continuous improvement, refining systems and creating efficiencies. Work within a framework of internal procedures and working practices to ensure compliance with regulatory requirements
    Interface with key safety and governance stakeholders across Pharmanovia and partners
    Management of Global Labelling Information in appropriate systems and eDMS
    Keep project team abreast of regulatory decisions, evolving regulatory requirements, risks, and mitigation plans
    Communicate with local health authority (HA), local consultancies/ distributors and internal stakeholders, as needed, to ensure timely and accurate submissions
    Maintain controlled records for historical, current, and ending labelling changes, and communicate labelling changes to stakeholders at the time of implementation
    Work closely with other Regulatory Affairs colleagues, Artwork and Supply chain colleagues
    Responsible for proofreading, peer-review of submission packages, review and approve of product information, including artworks
    Work with colleagues in markets worldwide to ensure implementation of the company core datasheet into local prescribing/patient information

    Candidates with proven relevant experience gained within a pharmaceutical company, CRO, or similar organisation, are likely to have the skills required to be successful in this role.

    Bachelor's degree in science/health discipline
    Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook
    Awareness of regulatory submission structure and content (e.g., Experience in compliance and maintaining product life cycle databases and RIMs systems
    Ability to effectively communicate with regulatory authorities
    Awareness of EU regulatory framework and guidelines
    Strong attention to detail and accuracy, including composing and proofreading materials
    Ability to write scientific and technical documents is desirable
    Excellent time management skills with demonstrated ability to juggle multiple competing tasks and demands
    Second language, especially German, Italian, or French, is desirable

    We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

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