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.
Position Summary & Responsibilities:
Reporting to the Director of Regulatory Affairs, the Manager of Regulatory Affairs will work with internal and external stakeholders to prepare regulatory submissions, archive records, track commitments, etc. in a growing organization.
- 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 regard 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.
- Bachelor’s degree with 4+ 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.
- Remote candidates considered
Benefits and Perks:
Aura offers a great benefit package which includes:
- Health insurance with FULL premium coverage
- 401K with company match
- Employee Stock Purchase Program (ESPP)
- Competitive Paid time off (PTO)
- Company-paid short & long-term disability insurance and life insurance
Interested in applying? Please apply through our LinkedIn posting: https://www.linkedin.com/jobs/view/3217487887