Director of Pharmaceutical Regulatory Strategy

3 weeks ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time

Overview

Takeda Pharmaceutical is seeking a highly experienced Regulatory Affairs Director, CMC Small Molecules to lead global cross-functional teams and ensure compliance within the organization.

Job Summary

This role requires an advanced degree in a scientific discipline and 10+ years of pharmaceutical regulatory experience, including late-stage development and international experience. The ideal candidate will have a proven ability to liaise with regulatory agencies and evaluate new business development opportunities.

Responsibilities

  • Develop and execute regulatory strategies for assigned products and staff.
  • Communicate with international health authorities and negotiate as necessary.
  • Provide expertise for new business development and due diligence activities.
  • Lead team members in defining CMC content requirements and reviewing submissions for conformance.
  • Evaluate new business opportunities and participate on due diligence teams.

Requirements

The successful candidate will have significant small molecule experience and be able to independently plan, execute, and manage regulatory submissions. They will also be a member of global cross-functional teams and contribute to business process development and enhancement.

Benefits

Takeda Pharmaceutical offers a competitive salary range of $185,000 - $225,000 per year, depending on experience, plus benefits and a comprehensive relocation package.



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