Senior Regulatory Affairs Officer

Shorla Oncology develops innovative solutions into effective oncology treatments to improve patients’ lives. The patients’ needs are at the heart of our innovation, ensuring we deliver affordable, accessible medicines and provide a significant clinical impact.

Shorla Oncology has core values of compassion, commitment, innovation, tenacity and collaboration. At Shorla Oncology we feel passionately about the work that we do and the patients that inspire us. Our focus on oncology gives us the opportunity to truly impact lives. As employees, we are here because we want to be part of a global team, working together to bring hope to underserved patient populations. Our team is smart, collaborative, creative, compassionate and accomplished. Each day we challenge each other to work on solutions for hope while building a company and culture focused on the future. The patient is at the center of our innovation, our decisions are driven by science while our Shorla Oncology colleagues motivate us to grow and develop every day.

We have recently received U.S. FDA approval for our lifesaving drug to treat T-cell Leukemia. At this milestone moment in our company’s growth, we are seeking a Senior Regulatory Affairs Officer to join our experienced team, working directly with our Regulatory Affairs Manager and other senior level team members. This position will play a pivotal role in our organization through product development, submission and approval, post approval and lifecycle management, and other strategic activities.

The successful candidate will have at least 3 years work experience in a regulatory role within the pharmaceutical industry and a third level degree in a science discipline. The Senior Regulatory Affairs Officer will have in depth knowledge of US FDA guidelines and EU regulations and directives associated with the regulation of pharmaceutical products. The successful candidate will enjoy a flexible working environment and will be keen to work in a fast paced environment in a scaling company. We have offices in Cambridge, Massachusetts and also in Tipperary, Ireland.

Shorla Oncology is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.