Regulatory Affairs Project Lead MAAs

6 giorni fa


Roma, Lazio, Italia PAREXEL A tempo pieno
Join Our Team as a Senior Regulatory Affairs Consultant

We are seeking a highly skilled and experienced Senior Regulatory Affairs Consultant to join our team at Parexel. As a Senior Consultant, you will be responsible for leading internal projects on behalf of our clients, providing a broad range of consulting services, and working within project guidelines to identify, refine, and address client issues and achieve project objectives.

Key Responsibilities:
  • Project Initiation Management: Own the client relationship and responsibility for client communication ensuring high client satisfaction.
  • Project Execution Management: Lead client kick-off meeting and discussions with client, establishing client expectations for project delivery, communication, and client-specific metrics.
  • Project Implementation, Control & Evaluation: Manage the project such that it is completed within budget, schedule, and according to contract specifications.
  • Project Closure Management: Oversee all administrative closeout procedures are completed, according to Project Closeout Checklist.
Requirements:
  • 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.
Location:

Ireland-Remote; Croatia-Remote; Hungary-Remote; Czech Republic-Remote; Spain-Remote; United Kingdom-Uxbridge-Remote; Italy-Remote; Poland-Remote; Romania-Remote.

Type: Full time.



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