Remote Otter LogoRemoteOtter

Regulatory Affairs Manager - Remote

Posted 9 weeks ago

Overview

This position involves managing regulatory processes and preparing documentation for submissions to health authorities, ensuring compliance with global regulations.

In Short

  • Manage regulatory documentation for health authority submissions.
  • Plan and compile documents for INDs, NDAs, and other submissions.
  • Provide regulatory direction to project teams.
  • Maintain timelines for regulatory submissions.
  • Review critical documents for compliance.
  • Coordinate with vendors for submission planning.
  • Maintain regulatory databases.
  • Work independently on time-sensitive assignments.
  • Communicate regulatory expectations to teams.
  • Stay updated on global regulations and guidelines.

Requirements

  • Bachelor’s degree in life sciences preferred.
  • 8 years of experience in regulatory affairs.
  • Experience with eCTD formatted submissions.
  • Ability to lead responses to health authorities.
  • Excellent communication and time management skills.

Benefits

  • Patient Days for direct engagement with patients.
  • A culture focused on patient-first values.
  • Decentralized model for decision-making.
  • Opportunities for career advancement.
  • Access to learning and development resources.
  • Market-competitive compensation and benefits.
  • Flexible PTO.
  • Commitment to Diversity, Equity & Inclusion.

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