Job Description
● 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 medical evaluation board and supervising the registration procedure in order to obtain and maintain registration through interaction with health authorities. ● Ensuring compliance with regulations set by high 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.
Requirements
● Understanding 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 skills. ● Problem-solving skills. ● Team-working skills. ● Presentation skills. ● At least one year of experience. ● Excellent computer skills, especially MS Office. ● Fluent in English. ● Age range: 25 to 35 years old. ● An end-of-service card is mandatory for men.
Employment Type
- Full Time
Job Category
Seniority
Details
Employment type
- Full Time
Job Category
Seniority
