Regulatory Affairs Manager

Remote,

are currently seeking a ­­­­­­­­Remote Regulatory Affairs Manager for a prominent client of ours. Details for the position are as follows:

Job Description:

  • Shift: 20hrs a week.
  • Pay: $100-$121.15/hr depending on experience.
  • This is a temporary assignment that is slated for 8 months with possibility for extension or conversion based on performance and budget.
  • Position is responsible for providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, working flexibly within and across regions to provide broad operational support to ensure the delivery of project and business objectives. Position is also responsible for ensuring global regulatory CMC combination product / device strategy for assigned combination products are consistent with the team and business goals and meet Health Authority requirements.

Qualifications:

  • 5+ years of experience working within regulatory affairs working on combination products.
  • Experince within regulatory CMC submissions.

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