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*