Regulatory Affairs Director

5 days ago


Massachusetts, United States Aura BioSearch Full time
Company Overview

Aura BioSearch is a leading bio-pharmaceutical company driven by an entrepreneurial mindset and a team-oriented culture. Our mission is to develop innovative therapies that improve patients' lives.

Job Summary

We are seeking a highly experienced Vice President of Regulatory Affairs to oversee all aspects of Regulatory operations. This role involves providing strategic and operational leadership to ensure the efficiency and effectiveness of the Regulatory team and the integrated group.

About You

The ideal candidate will have extensive expertise in drug development, with over 20 years of experience in the bio-pharmaceutical industry, at least 15 years in Regulatory within pharmaceutical development. Proven track record of successful regulatory submissions to the FDA and/or other health authorities, including EMA. Strong ability to apply scientific principles to regulatory issues, analyze data, and draw valid conclusions.

Responsibilities
  • Lead the development and execution of global regulatory strategies to support development programs and market applications.
  • Ensure effective implementation of regulatory strategies.
  • Manage the Regulatory team in developing submissions and collaborating across functions.
  • Oversee planning and execution of submissions, ensuring timely and high-quality documentation.
  • Interpret and communicate data effectively within cross-functional teams and with regulatory authorities.
  • Incorporate corporate planning and other factors into regulatory strategies, maintaining alignment with global health authority requirements.
  • Prepare risk assessments on regulatory topics, predicting potential issues and developing contingency plans.
  • Build and maintain strong relationships with internal and external stakeholders.
Qualifications
  • Bachelor's degree in Biochemistry, Biology, Chemistry, or a related field; advanced degree preferred.
  • At least $250,000 per year salary, depending on experience.
  • MUST be resident in Massachusetts.


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