Regulatory Affairs Project Lead

hace 1 mes

Alcobendas, Madrid, España Parexel A tiempo completo

About the Role

We are seeking a highly experienced Senior Regulatory Affairs Consultant to lead internal projects on behalf of Parexel Clients. As a Senior Consultant, you will be responsible for 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 meetings and discussions, establishing client expectations for project delivery, communication, and client-specific metrics.
  • Project Implementation, Control & Evaluation: Manage projects to ensure completion within budget, schedule, and according to contract specifications.
  • Project Closure Management: Oversee administrative closeout procedures and review project contracts.

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.
  • Fluent in English.

About Parexel

Parexel is a global biopharmaceutical services company that provides a range of services to support the development and delivery of innovative therapies.

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