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Job ID: 100 Job Title: Principal Regulatory Affairs Executive Job Type: Hire Type: Direct Hire Level: Experienced - Non Managerial Recruiters: Hannah Woodward,Sophie Taylor City: Harefield Country England

Job Description

Description: • The Principal Regulatory Affairs Executive is responsible for preparing high quality documentation for all regulatory submissions, primarily CMC variations, with minimum supervision; liaising with relevant departments to ensure regulatory requirements for these submissions are met; proactively communicating with regulatory authorities in order to expedite approval of these submissions. • The Principal Regulatory Affairs Executive may also be responsible for planning regulatory submissions, mentoring and/or supervising the work of junior Regulatory Affairs staff, and may be required to lead cross-functional project teams as required. Requirements/Qualifications: Responsibilities: • To prepare and submit 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 proactively communicate with regulatory authorities in order to expedite approval of submissions • To provide regulatory advice and support to other areas of the Company • To prepare and maintain product labelling for appropriate markets in cooperation with local regulatory and commercial contacts • To anticipate and resolve complex regulatory issues • To actively participate as primary regulatory resource in cross-functional project teams • To guide and manage direct reports, if appropriate • To prepare 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 • To interact with industry trade associations and external consultants as necessary

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