Studying scientific and legal documents, keeping up to date with changes in regulatory legislation and guidelinesGathering, evaluating, organizing, managing, collating information and gap analysis in a variety of formatsPreparing documents and dossiers for submission/registration dossiers to the Medicine Evaluation Board and supervising the registration procedure to obtain and maintain registration through interaction with health authoritiesEnsuring compliance with regulations set by highly regulated agencies (ICH/EMA/FDA/WHO and other international guidelines)Planning, undertaking, and overseeing product studies/clinical trials and regulatory inspectionsOutlining requirements for labeling, storage, and packagingLiaising and negotiating with regulatory authoritiesProviding advice about regulations to other departmentsEnsuring that quality standards are met and submissions meet strict deadlinesQualifications:Understanding of both legal and scientific mattersAbility to grasp new concepts quickly and to assimilate and evaluate scientific dataTime management skills/ the ability to work under pressure and to strict deadlinesExcellent organizational and project management skills: coordinate complex activities, often with competing prioritiesAbility to pay particular attention to detailsWell-developed written and oral communication and interpersonal skills/strong negotiation skillProblem-solving skillsTeam-working skillsPresentation skillsIntegrity and a professional approach to workHaving a related background has a positive point (at least 1 year).Excellent computer skills, especially OfficeForeign languages:English: fluent in writing/speaking/ListeningOther languages have a positive point.

Studying scientific and legal documents, keeping up to date with changes in regulatory legislation and guidelines
Gathering, evaluating, organizing, managing, collating information and gap analysis in a variety of formats
Preparing documents and dossiers for submission/registration dossiers to the Medicine Evaluation Board and supervising the registration procedure to obtain and maintain registration through interaction with health authorities
Ensuring compliance with regulations set by highly regulated agencies (ICH/EMA/FDA/WHO and other international guidelines)
Planning, undertaking, and overseeing product studies/clinical trials and regulatory inspections
Outlining requirements for labeling, storage, and packaging
Liaising and negotiating with regulatory authorities
Providing advice about regulations to other departments
Ensuring that quality standards are met and submissions meet strict deadlines
Qualifications:
Understanding of both legal and scientific matters
Ability to grasp new concepts quickly and to assimilate and evaluate scientific data
Time management skills/ the ability to work under pressure and to strict deadlines
Excellent organizational and project management skills: coordinate complex activities, often with competing priorities
Ability to pay particular attention to details
Well-developed written and oral communication and interpersonal skills/strong negotiation skill
Problem-solving skills
Team-working skills
Presentation skills
Integrity and a professional approach to work
Having a related background has a positive point (at least 1 year).
Excellent computer skills, especially Office
Foreign languages:
English: fluent in writing/speaking/Listening
Other languages have a positive point.