Senior Regulatory Affairs Expert for CMC Development

4 days ago


Jackson, Mississippi, United States Firefingrill Full time
Job Overview

Fueled by innovation, Firefingrill is a pioneering company seeking a Senior Regulatory Affairs Expert to lead our CMC development strategy. This role will play a pivotal part in expediting global clinical trials, market registrations, and post-approval submissions.

About the Role

We are committed to harnessing expertise to drive growth, and this position will be instrumental in leveraging your knowledge of global regulations, guidelines, and regulatory requirements to navigate complex technical agendas.

Key Responsibilities
  • Cross-functional Collaboration: Partner with internal stakeholders to provide strategic direction, ensuring seamless alignment between regulatory and technical objectives.
  • Regulatory Compliance: Develop and implement effective compliance strategies, maintaining up-to-date understanding of evolving regulations and guidelines.
  • Documentation and Reporting: Prepare and submit high-quality documents, including but not limited to, CMC sections for global clinical trial applications, marketing authorization submissions, and post-approval reports.
Requirements and Qualifications

To succeed in this role, you should possess a strong background in regulatory affairs, coupled with excellent communication and project management skills. Proficiency in navigating global regulatory landscapes is essential.

Estimated Salary: $120,000 - $180,000 per year

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