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| Job Location | Pune |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Legal Support Services,Company Secretary |
| EmploymentType | Full-time |
Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements.Key duties of the job include:studying scientific and legal documentsgathering, evaluating, organising, managing and collating information in a variety of formatsensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)maintaining familiarity with company product rangesplanning, undertaking and overseeing product trials and regulatory inspectionskeeping up to date with changes in regulatory legislation and guidelinesanalysing complicated information, including trial dataoffering advice about company policies, practices and systemsobtaining marketing permissionoutlining requirements for labelling, storage and packagingusing a variety of specialist computer applicationsliaising and negotiating with regulatory authoritiesproviding advice about regulations to manufacturers/scientistswriting comprehensible, user-friendly, clear product information leaflets and labelsensuring that quality standards are met and submissions meet strict deadlinespreparing documentation.
Keyskills :
evaluationlegislative relationsdocumentationleafletsregulatoryquality standardshealthcarecompliancelegalstoragemarketingcosmeticsagencycollatingsetvalidationveterinaryregulatory affairstrialsfda