● 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 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 of both legal and scientific matters.
● Ability to grasp new concepts quickly and to assimilate and evaluate scientific data.
● Time management skills.
● 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 detail.
● Well-developed written and oral communication and interpersonal skills.
● Strong negotiation skills.
● Problem-solving skills.
● Team-working skills.
● Presentation skills.
● Integrity and a professional approach to work.
● At least three years of experience.
● Excellent computer skills, especially MS Office.