Job Description
Are you ready to accelerate the delivery of life-saving cancer therapeutics to patients worldwide? Aura Therapeutics is a pioneering, clinical-stage biopharmaceutical company dedicated to developing next-generation oncology treatments. We are seeking a highly strategic, detail-oriented Senior Regulatory Affairs Manager to join our elite team in Boston.
In this high-impact role, you will define and execute the regulatory pathway for breakthrough investigational products. You will act as the primary liaison with global regulatory bodies, ensuring seamless navigation through all phases of clinical development and commercialization. If you are passionate about transformative science and possess a rigorous track record of successful regulatory submissions, Aura Therapeutics offers a collaborative, high-reward environment where your expertise will directly influence patient outcomes.
Responsibilities
- Lead the compilation, scientific review, and timely submission of high-quality IND, NDA, and BLA filings to the FDA, EMA, and other international health authorities.
- Serve as the primary point of contact with regulatory agencies, spearheading strategy for meetings, preparing briefings, and managing post-meeting deliverables.
- Provide strategic regulatory guidance to cross-functional program teams (including Clinical Development, Nonclinical, and CMC) to accelerate development timelines.
- Monitor and interpret emerging regulatory trends, guidelines, and competitor landscapes to adapt and optimize internal global regulatory strategies.
- Oversee the preparation and maintenance of investigator brochures, orphan drug applications, expedited review requests (e.g., Breakthrough Therapy, Fast Track), and annual reports.
- Mentor and guide junior regulatory team members, fostering a collaborative culture of continuous learning and compliance.
Qualifications
- Bachelor's or Master's degree in a life sciences discipline (e.g., Pharmacy, Pharmacology, Molecular Biology); a PharmD or PhD is highly preferred.
- Minimum of 6-8 years of progressive regulatory affairs experience within the biotechnology or pharmaceutical industry.
- Direct experience authoring and coordinating successful clinical regulatory submissions (IND/NDA/BLA) within the oncology therapeutic area.
- Robust knowledge of FDA, EMA, and ICH regulations, clinical trial design, and drug development paradigms.
- Proven track record of direct, successful interactions and negotiations with regulatory agency representatives.
- Exceptional verbal and written communication skills, with the ability to articulate complex scientific and regulatory concepts to diverse stakeholders.