Regulatory Affairs Specialist

I am partnering with a Mid size Global Pharmaceutical client who are currently recruiting for a Regulatory Affairs Executive who will be responsible for UK specific regulatory oversight on marketed products , improving QRVI systems and processes , reviewing documents and managing the Affiliate is in line with the MHRA and European Guidance on any regulatory activities for all relevant products.

1 day per week in their offices

The ideal person with have the following skills , experience and personal attributes and have around 3-5 years experience

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• competence in:
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• Regulatory variations for MHRA
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• Understanding of variations for EMA
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• Experience of working in a matrix environment
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• Self starter, not afraid of change, speaking up, wants to improve processes
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• Detailed approach to work
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• Team player
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• Ensure that prevailing legislation, GCP, Ethical Committee, and SOP and local requirements, and the appropriate Codes of Practice requirements are fulfilled
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• Contribute proactively to a credible image for the affiliate in the local Health Care and Medical community
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• Organise internal audits for the affiliate, to evaluate the compliance to local regulatory requirements, and corporate requirements
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• Corporate image and Compliance
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Special Competencies / Other Requirements

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• Degree in pharmacy, life science or a recognised healthcare professional degree / qualification.
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• Good knowledge of Regulatory legislation where appropriate
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• Practical experience in interacting with and influencing the MHRA
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• Experience in process mapping and writing process documents and driving continuous improvement
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• Flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads, facilitates and drives change where appropriate
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• Challenges and questions ways of working to seek improved processes
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• Excellent attention to detail
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Your main responsibilities will involve:

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• Striving to constantly improve the QRVI systems and processes
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• Representing the RA function within Regulatory meetings, giving advice to maintain/improve quality performance
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• Ensures that the Affiliate is in line with the MHRA and European Guidance on any regulatory activities for all relevant products
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• Reviewing documents that directly affect RA activities
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Key accountabilities

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• Responsible for UK specific regulatory oversight on marketed products:
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• Prepare and deliver regulatory operational plans for assigned projects/products
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• Advising on local strategy and procedures
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• Serving as the primary regulatory liaison between:
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• MHRA and OPUK
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• OPUK and the wider business
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• Preparation and submission of variations to the MHRA
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• Working with the Regulatory Publishing Group as required
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• Updating of Module 1 (Module 1 of the CTD) in order to assist in the preparation of dossiers for MA application
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• Ensure maintenance of regulatory databases and trackers
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• Provide regulatory input on artwork and product information
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• Regulatory compliance – write, review, develop, validate, and maintain local regulatory SOPs in line with local regulatory legislation, guidelines, issues, practices, and corporate procedures
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• Responsible for the management of release and updating of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL)
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• Attend internal and external meetings as required, to influence and drive the regulatory requirements
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