Interim Senior Regulatory Project Manager
Our client, based in the UK, is a well funded, small, rapidly growing and ambitious speciality pharma company currently at a very exciting stage in its life. The company already has one product commercialised and has a promising pipeline of other products in Pre-Clinical, and Phases I, II and III.
The need has emerged for a talented, motivated and experienced Senior Regulatory Project Manager to join the company in what is a critically important role.
This is an Interim role, likely to be (initially) of 3-6 months duration and demand 3-4 days / week. The majority of the work will be conducted from a home base, although travel to London for occasional meetings will be necessary.
Reporting directly to the company’s Head of Regulatory Affairs, key areas of responsibility are as follows:
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Support the Head of Regulatory in devising and developing the Company’s regulatory strategies for all development projects, manufacturing improvements, and the continued registration and licensing for all established products when applicable, including lifecycle management.
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Act as a point of contact for all regulatory interactions with relevant agencies, including, but not limited to, application for and maintenance of clinical trial/investigational new drug applications, preparing all pre- and post- meeting strategies, and responses and life cycle management.
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Support the Company at regulatory meetings with the Food and Drug Administration, European Medicines Agency, and other global regulatory agencies as required.
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Preparation of registration dossiers and submission of Marketing Authorisation Applications (MAAs) / New Drug Applications in line with regulatory authority requirements; and interaction with all licensing partners, and designated vendors such as Contract Research Organisations and others where applicable, to facilitate the submissions of MAA’s in their territories
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Support the Company in the preparation of all product information (including artwork), and provide advice and support in conjunction with the Head of Regulatory to ensure all manufacturer / importer and wholesale dealer licenses are maintained, as well as regulatory compliance with all change controls and Standard Operating Procedure (SOP) activities.
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Work closely with the Company’s Head of Quality, and Director of Chemistry, Manufacturing and Controls, to ensure that clinical and manufacturing activities are conducted in accordance with Good Clinical Practice, Good Manufacturing Practice, and the associated local statutory requirements.
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Support the Head of Regulatory in the design and planning of the development programs, both for the Company’s lead products and also for the Company’s product pipeline, to ensure they meet appropriate regulatory requirements and standards.
This is an excellent opportunity in an outstanding company of real potential. If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to gn@interea.co.uk
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