Responsibilities
* Studying scientific and legal documents
* 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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