Regulatory Affairs Lead

Job Description

• Communicating regulatory information to multiple departments and ensure that information is interpreted correctly.
• Accompanying development projects, issuing development-accompanying and technical documentation for medical devices, revising already existing technical documentations
• Communication with responsible regulatory authorities (national/international) as well as with notified bodies
• Examining the conformity (all documents for approval must be compliant to all relevant regulations, rules, and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
• Being the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of medical devices
• Staying informed about any changes in legislation etc. organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish work.
• Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.
• Maintaining current knowledge of relevant regulations, including proposed and final rules.
• Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.
• Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products

Job Requirements

• Degree in Science or Pharmacy or related discipline is a must, professional post graduate degree is a plus.
• High English Proficiency.
• At least 5- 7 Years relevant experience in regulatory national and/ or regional scope of work.
• Preferable to have experience in importation/ release process of medicinal/ biological products.
• Ability to interact and communicate effectively and efficiently with other functional departments in the business and with Health Authorities
• Good knowledge of different regulatory dossiers: CTD, e-CTD, NeeS.
• Good, solid interpersonal communication and organisation skills.
• Good understanding of the regulations and related guidelines in Egypt.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.