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* Studying scientific and legal documents组选
* Gathering, evaluation, organizing, managing and collating information in a variety of formats.
* Ensuring compliance with regulations set by the legal authorities as Medicines and Medical devices Regulatory Agency (AEMPS).
* Maintaining familiarity with company product ranges.
* Planning, undertaking, and overseeing product trials and regulatory inspections.
* Keeping up to date with changes in regulatory legislation and guidelines.
* Analyzing complicated information, including clinical trial data.
* Offering advice about company policies, practices and systems.
* Obtaining marketing permission.
* Outlining requirements for labelling, storage and packaging.
* Using a variety of specialist computer applications.
* Liasing and negotiating with regulatory authorities.
* Providing advice about regulations to manufacturers/scientists.
* Writing comprehensible, user-friendly, clear product information leaflets and labels.
* Ensuring that quality standards are met and submissions meet strict deadlines.
* Preparing documentation.
* Experience in Pharma, OTC and pharmaceutical register*
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