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St Albans

    Regulatory Affairs Manager - St Albans, United Kingdom - Achieva Group Limited

    Achieva Group Limited
    Achieva Group Limited St Albans, United Kingdom

    2 weeks ago

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    Employee
    Description

    This position is responsible for post approval changes of Marketing Authorisations, and product life cycle management.

    Tasks


    Duties inclusive but not limited to the below:

    • Accountable for management of post-approval filings and life cycle maintenance supplements of Marketing Authorisations like variations, notifications, labelling updates, renewals, sunset clause etc across product portfolio.
    • Maintenance of MIA and WDA including API import registration.
    • Filing strategy and managing submission timelines.
    • Identifying and remediating compliance gaps if any.
    • Gather, consolidate, analyse documentation and submit regulatory filings.
    • Coordinate and prepare written responses to requests for information from regulatory authorities.
    • Monitor status of regulatory applications.
    • Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product.
    • Provide product & regulatory expertise and clarification on RA requirements for post marketing changes and new product introduction.
    • Provide regulatory support to supply chain, commercial teams, QP, QPPV, Quality 3rd Party contract management as necessary.
    • Contribute to the creation, maintenance and continuous improvement of Regulatory processes, policies and systems.
    • Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products.
    • Build good working relationship with CMOs and cross functional teams within the organisation.
    • Supervise assigned team members with respect to management and training.
    • Shall participate in resource planning and recruitment procedure.
    • Ensure compliance with company policies, procedures and training expectations.
    • Performs other appropriate duties, where necessary

    Requirements


    Required Skills:

    • understanding of GMP, Quality and Regulatory requirements.
    • communicative and able to work with a range of stakeholders, at all levels, both internally and externally.
    • Proficiency in publishing and compilation of eCTD submissions, eCTD validation and viewing tools.
    • Maintaining an awareness changing regulatory requirements.

    For further details, please contact Tim Barratt on

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