Chief Regulatory Affairs Strategist

7 days ago


Princeton, New Jersey, United States TK-CHAIN LLC Full time
Job Overview

The Chief Regulatory Affairs Strategist plays a pivotal role in TK-CHAIN LLC drug development programs, ensuring compliance with US regulatory guidelines and federal regulations.

This position is responsible for integrating knowledge of pharmaceutical drug development into all aspects of the company's drug development policies and procedures, ensuring a compliant state of regulatory commitment.

Estimated Salary:

$185,000 per year

Key Responsibilities
  • Acts as liaison between TK-CHAIN LLC and FDA for assigned projects.
  • Manages all regulatory activities associated with TK-CHAIN LLC development projects.
  • Coaches & directs team to produce excellent work; provides development opportunities for team to reach their full potential.
  • Participates in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals.
Requirements
  • Advanced degree in a life science.
  • Minimum of 12 years of pharmaceutical industry experience, at least 10 of those years in Regulatory Affairs.
  • Must have at least 6 years of managerial experience.
Essential Skills
  • Exhibits excellent written, verbal, and negotiation skills.
  • Strong ability to prioritize, multi-task, and work in a fast-paced and dynamic environment.
  • Strong critical and logical thinker with the ability to analyze problems.


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