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Senior Regulatory Strategist

1 month ago

Nagpur, Maharashtra, India Parexel Full time
About the Role

We are seeking a highly experienced Clinical Regulatory Leader to join our Regulatory Strategy team at Parexel. As a Technical Vice President, you will play a critical role in shaping the development strategies of pace-setting biopharma companies.

Key Responsibilities
  • Lead teams of respected SMEs in supplying answers to clients
  • Develop and implement business solutions addressing specific client needs
  • Provide guidance to project team members and act as a mentor to junior staff
  • Participate in the development of new service offerings, consulting models, and methodologies
  • Facilitate improvements to Parexel business processes and new service and consulting model development
Requirements
  • MD or PhD required
  • Minimum 15+ years experience with expert-level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications
  • Extensive Oncology experience is required
  • Ability to travel up to 20-30% domestically and/or internationally for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
About Parexel

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.