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Executive Director, Regulatory Affairs Lead

2 months ago

Waltham, Massachusetts, United States Trebla Talent Full time

Job Summary:

We are seeking a highly experienced Executive Director, Regulatory Affairs to join our team at Trebla Talent. As a pivotal leader, you will drive strategic regulatory decisions across our entire portfolio, leading a growing regulatory team and reporting directly to the c-suite.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with global regulations and FDA guidelines.
  • Lead a team of regulatory professionals in the preparation and submission of IND/CTA, BLA/MAA, and other regulatory documents.
  • Collaborate with cross-functional teams to ensure regulatory alignment with business objectives.
  • Stay up-to-date with changing regulatory landscapes and provide expert guidance to the organization.

Requirements:

  • 10+ years of experience in Regulatory Affairs within a pharmaceutical or biotech setting.
  • Proven expertise in Oncology/ImmunoOncology, with a strong understanding of FDA and global regulations.
  • Previous experience in a small company setting, with a track record of driving regulatory compliance and strategy.

What We Offer:

At Trebla Talent, we offer a dynamic and collaborative work environment, with opportunities for professional growth and development. If you are a motivated and experienced regulatory professional looking for a new challenge, we encourage you to apply.