Chief Regulatory Strategy Officer

1 week ago

Massachusetts, United States Aura BioSearch Full time

Aura BioSearch is a leading bio-pharmaceutical company dedicated to developing therapies that improve patients' lives. We are driven by an entrepreneurial mindset and a team-oriented culture.

Position Overview

The Chief Regulatory Strategy Officer will oversee all aspects of regulatory operations, reporting directly to the Senior Vice President of Regulatory. This role involves providing strategic and operational leadership to ensure efficiency and effectiveness of the Regulatory team and integrated groups. The ideal candidate will have extensive expertise in drug development.

Key Responsibilities:

  • Develop and execute global regulatory strategies to support development programs and market applications.
  • Ensure effective implementation of regulatory strategies.
  • Lead the Regulatory team in developing submissions and collaborating across functions.
  • Oversight of planning and execution of submissions, ensuring timely and high-quality documentation.
  • Interpret and communicate data effectively within cross-functional teams and with regulatory authorities.
  • Maintain alignment with global health authority requirements by incorporating corporate planning and other factors into regulatory strategies.
  • Prepare risk assessments on regulatory topics, predicting potential issues and developing contingency plans.
  • BUILD AND MAINTAIN STRONG RELATIONSHIPS WITH INTERNAL AND EXTERNAL STAKEHOLDERS.
  • Ensure dossiers comply with ICH and local requirements across various countries.

Qualifications:

  • Bachelors degree in Biochemistry, Biology, Chemistry, or a related field; advanced degree preferred.
  • Over 20 years of experience in the bio-pharmaceutical industry, with 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.
  • Effective leadership skills, with experience leading both direct reports and integrated teams.
  • Excellent interpersonal, verbal, and written communication skills, with the ability to influence and lead others.
  • Comfortable working in a fast-paced environment with minimal direction, and adaptable to changing priorities.

NB: MUST BE RESIDENT IN MASSACHUSETTS. On-site attendance is expected as part of scale-up.

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