Regulatory Affairs

A Regulatory Affairs professional can be involved in all of the following activities, depending on his or her academic background; previous experience and personal skills:

• Compilation and coordination of applications to regulatory authorities world-wide
• Preparation and review of administrative and technical regulatory documents
• Advice on regulatory and drug development strategy
• Interaction with regulatory authorities on behalf of clients
• Management of regulatory projects, including oversight of the regulatory project team; control of budget; contract management etc.
• Training of clients on subjects within the area of expertise

Profile:

• Life Sciences or Science Degree
• Previous experience in Regulatory Affairs or related disciplines is an asset

Competencies:

• Good command of English (verbal and written)
• Strong communication skills (verbal / written)
• Ability to give careful attention to detail and accuracy
• Strong leadership skills
• Good organisational and planning skills
• Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
• Strong team player
• Self motivated and assertive
• Creative and the ability to think ‘outside the box’