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    Team Lead Development - Leiden, Nederland - Astellas

    Astellas
    Astellas Leiden, Nederland

    1 week geleden

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    Beschrijving

    About Astellas:
    At Astellas we are a progressive health partner, delivering value and outcomes where needed.


    We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.


    We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.


    Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.

    We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.


    The Rest of World Regulatory Labeling Lead is a pivotal role at Astellas Pharma Global Development, reporting directly to the Head of Regulatory CCDS and Labeling.

    As a key member of the labeling leadership team, you will play a crucial role in providing regulatory leadership and support for CCDS and product labeling across the Rest of World Established and International market products.

    Your responsibilities will encompass new product labeling development, life cycle management, and ensuring strict compliance with regulatory guidelines.

    At Astellas we recognise the importance of balancing your work and home life.

    This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.

    Manage the labeling content review and approval process, ensuring regulatory, therapeutic area, and clinical knowledge is applied.

    Advanced experience in the pharm industry, preferably including area of labeling development and review for prescription pharmaceutical or similarly regulated industry.

    Excellent planning, organizational, analytical, problem-solving, and decision-making skills.

    Proficiency in regulations, guidelines, and precedents related to pharmaceutical product development, with a focus on product labeling and packaging.

    Proficiency in a second language is a plus.
    Strong computer skills, including electronic document management systems.

    Bachelor's degree in a life science field or equivalent.

    This is a permanent full-time position.
    Position is based in the United Kingdom or the Netherlands.
    This position is 100% home/remote based.

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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