Regulatory Affairs Project Lead MAAs

at  Parexel

We are currently looking for a Senior Regulatory Affairs Consultant (Project Lead)! As a Senior Consultant you will be responsible for leading internal projects on behalf of Parexel Clients. A Senior Consultant provides a broad range of consulting services and works within project guidelines to identify, refine, and address client issues and to achieve project objectives. We are looking for an experienced candidate with strong organizational skills, the ability to prioritise and influence internal teams, as well as developing client relationships. You will provide guidance to project team members on technical/process issues. In this role you will have solid EU regulatory experience, e.g., MAA preparation and submission.

SKILLS AND EXPERIENCE REQUIRED FOR THE ROLE:

• University Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
• PMP or equivalent - nice to have
• Extensive years of Regulatory Affairs experience in an industry-related environment
• CRO experience
• Experience in MAA preparation and submissions
• Project management knowledge and experience
• Financial management skills
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Fluent in English