International Regulatory affairs specialist

Key duties:

• 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 heath 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 labelling, 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 related background has a positive point (at least 1 year).
• Excellent computer skills, specially Office

Foreign languages: 
English: fluent in writing/speaking/listening
*Other languages have a positive point.