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Regulatory Affairs Strategy Lead - Associate Director

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  • Date Posted:

    5/30/2025

  • Remote Work Level:

    100% Remote

  • Location:

    Remote in MA

  • Job Type:

    Employee

  • Job Schedule:

    Full-Time

  • Career Level:

    Senior Level Manager (Director, Dept Head, VP, General Manager, C-level)

  • Travel Required:

    No specification

  • Education Level:

    Bachelor's/Undergraduate Degree,BS

  • Salary:

    We're sorry, the employer did not include salary information for this job.

  • Categories:

    Product Manager,  Project Manager,  Operations

About the Role

Title: Regulatory Affairs Strategy Lead (Associate Director)

Location: MA United States

Job ID: 19874

Job Description:

Our small to mid-size pharmaceutical client on the East Coast is looking to hire a Regulatory Affairs Strategy Lead (Associate Director) (REMOTE) to their team! They have an exciting small molecule pipeline of both early and late-stage oncology and rare disease programs! This role will act as a Regulatory Affairs Program Lead and be responsible for the oversight of clinical trial investigational new drug applications (INDs), clinical trial applications (CTAs) and marketing applications. In addition will finalize regulatory submission documents and regulatory submission. Other responsibilities include but not limited to:

  • Develop regulatory strategies for rare disease and/or oncology programs
  • Provide solid regulatory solutions and guidance to the cross-functional teams and senior management
  • Monitor global regulatory changes that may impact asset development
  • Provide tactical support and operational expertise with hands-on support as needed
  • Ensure compliance of regulatory strategies and submissions
  • Assess project plans and timelines; manage project teams effectively and collaboratively to ensure all projects are appropriately prioritized and key goals are met on time
  • Contribute to the continuous improvement of existing department processes and create new processes to support the evolution of the company

Requirements:

  • B.S/M.S. and 6+ years of work experience in pharmaceutical regulatory affairs
  • 5+ years of regulatory experience working with global development and submission plans
  • Global regulatory affairs experience working with both the US and EU
  • Working with small molecule programs/assets
  • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU
  • Must have experience filing INDs and/or NDAs and engagement with FDA and other regulatory bodies
  • MUST be able to work East Coast business hours
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