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...
- 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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