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Manager, Regulatory Affairs

3 months ago

Solapur, India Parexel Full time

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.



  • 10+ yrs relevant experience in Clinical Trial Regulatory Submissions.
  • Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.
  • Expertise in handling the CTIS database and submitting EU CTR is desirable.
  • Provides guidance to project team members
  • Works within broad project guidelines and facilitates issue and conflict resolutions
  • Prioritizes own workload and may prioritize the workload of the project team in order to achieve the project scope and objectives
  • Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
  • Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
  • Produces quality work that meets the expectations and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and PC are met
  • Assesses project issues and develops strategies to meet productivity, quality and project goals and objectives
  • Actively manages performance including typical HR activities for direct reports (i.e. performance management reviews, salary actions, bonuses, scorecards)
  • Assures PAREXEL policies and procedures are communicated to line personnel in alignment with their staff’s local country
  • Provides a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear
  • Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)