Careers

Sr Specialist / Manager, Regulatory Affairs

About Aura:

At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Location:

Based in the Company’s North Cambridge office, with <20% travel required.

Position Summary:

Reporting to the Head of Regulatory Affairs, the Senior Specialist / Manager of Regulatory Affairs will work with internal and external stakeholders to prepare regulatory submissions, archive records, track commitments, etc. in a growing organization.

Responsibilities include but are not limited to:

  • Coordinate and prepare document packages for regulatory submissions (such as initial INDs and amendments, CTAs, annual reports, briefing packages).

  • Participate in the development of processes and procedures relevant to the submissions.

  • Support communications to responsible regulatory agency personnel in regards to submissions.

  • Collaborate extensively with regulatory CROs for preparation, review, approval, and archiving of regulatory submissions.

  • Coordinate with external publishing vendor for on-time delivery of high-quality regulatory submission to regulatory agencies.

  • Monitor, track and provide project updates.

  • Maintain and update Regulatory databases, such as commitment trackers.

  • Manage regulatory documents in Electronic Document Management System (EDMS)

  • Develop regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.

  • Contribute to regulatory intelligence gathering activities.

  • Perform other duties as assigned.

Minimum Requirements:

  • Bachelor’s degree with 2+ years’ experience in a pharmaceutical Regulatory Affairs role; minimum of 3 years’ experience working in the biotech or pharmaceutical industry preferred.

  • Excellent written and verbal communication skills, including negotiation and influencing skills.

  • Solid understanding of regulations and experience in interpretation of guidelines.

  • Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.

  • Experience with regulatory submissions, including electronic submissions, e.g., INDs, CTAs, annual reports, safety reporting, etc.

  • Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.

  • Ability to work in a team environment.

  • Technical system skills (e.g., word processing, spreadsheets, databases, online research) including submission-ready formatting.

  • Some travel may be required.

How we Work:

Aura is powered by a passion for bringing together diverse people, ideas and technologies behind common purpose: to create breakthroughs in diseases with significant unmet medical needs.  We constantly seek opportunities to broaden our impact and reach, using new platforms and technologies, and partnering to ensure that our drug development expertise reaches its full therapeutic potential.

Qualified applicants please submit resume to hr@aurabiosciences.com. Please reference job title in email subject line.

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