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Job ID:
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99
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Job Title:
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Regulatory Affairs Executive
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Job Type:
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Hire Type:
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Direct Hire
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Level:
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Experienced - Non Managerial
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Recruiters:
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Hannah Woodward,Sophie Taylor
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City:
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Harefield
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Country
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England
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Description:
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• The Regulatory Affairs Executive is responsible for supporting coordinating and overseeing the regulatory strategy and execution of activities, in accordance to current regulation, agreed plan and internal QMS processes.
• The Regulatory Affairs Executive may also be supporting establishing plans for regulatory submissions, and may be required to lead cross-functional project meetings as required.
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Requirements/Qualifications:
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Qualifications
Good degree in a relevant life science subject or equivalent
Competencies
• Regulatory experience and general knowledge of worldwide regulatory requirements (including GMP, GLP and GCP)
• Understanding of the drug development principles and processes
• Proven experience in the life cycle maintenance of products approved via Decentralised, Mutual recognition as well as Centrally Authorised Procecure.
• Demonstrates an ability to analyse and summarise data
• Awareness of external regulatory environment
• Focuses on customer needs, follows up on commitments and requests
• Excellent interpersonal skills
• Excellent verbal and written communication skills
• Works cooperatively within a team and leads team as appropriate
• Able to work effectively, with supervision as deemed necessary
• Ability to communicate clearly in English
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Responsibilities:
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DUTIES & RESPONSIBILITIES:
• To support preparation and submission of high quality documentation for all regulatory submissions, following current best practice standards, including the preparation, when applicable, of ASMFs and submission of CEP applications.
• To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to in order to expedite approval of submissions
• To liaise with Partners for in licenced and out licenced products and secure that Marketing Authorisations are supported and/or maintained in accordance with agreements.
• To support preparation and maintenance of product labelling for appropriate markets in cooperation with local regulatory and commercial contacts
• To actively participate as regulatory resource in cross-functional project teams
• To support establishment and review plans for submissions within agreed timelines and ensuring alignment with agreed strategy
• To identify and provide information for incorporation in the Regulatory databases as appropriate
• To provide input into the budgeting process this may include information relating to regulatory fees required for prospective regulatory submissions
• To maintain the paper and electronic filing systems for assigned products/countries, following Records Retention procedures
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