Regulatory Affairs Project Lead MAAs
6 giorni fa
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.
- 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.
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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