
Executive / Sr.Executive-RA (Azico)
JOB_REQUIREMENTS
Employment Type
Not specified
Company Location
Not specified
- ensure that a company's products comply with the regulations of the regions where they want to distribute them
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keep up to date with national and international legislation, guidelines and customer practices
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collect, collate and evaluate scientific data from a range of sources
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develop and write clear arguments and explanations for new product licences and licence renewals
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prepare submissions of licence variations and renewals to strict deadlines
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monitor and set timelines for licence variations and renewal approvals
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advise scientists and manufacturers on regulatory requirements
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provide strategic advice to senior management throughout the development of a new product
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project manage teams of colleagues involved with the development of new products
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undertake and manage regulatory inspections
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review company practices and provide advice on changes to systems
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liaise with, and make presentations to, regulatory authorities
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negotiate with regulatory authorities for marketing authorization
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take part in the development of marketing concepts and approve packaging and advertising before a product's release.
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