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.
Shorla Oncology has an exciting opportunity for a Regulatory Affairs Officer to join our growing team. This position will afford exposure to a broad range of operational learning opportunities and professional development.
Key Responsibilities include:
* Manage regulatory dossier activities for new product introductions (authoring of CMC sections for regulatory submissions) and post-approval activities (variations, response to questions, annual reports, commercial marketing material submissions, and pharmacovigilance submissions).
* Reviews of labeling for initial submissions and in response to questions from authorities in line with FDA guidelines.
* Support the wider cross-functional team with new product introduction activities and technology transfer activities.
* Support product development team including execution of literature reviews on relevant topics.
* Support the Regulatory team by collecting and collating documents for regulatory submissions from 3rd party contract development laboratory and manufacturing documentation.
* Compile responses to health authorities ensuring responses submitted on time with input from other departments as needed.
* Liaise with and support other internal departments including the Director of Quality to support implementation and maintenance of the Quality Management System (QMS) and Director of Research and Development for submission compilation.
* Support regulatory license applications.
Required Experience and Education:
* Education – A relevant honours degree in chemistry, pharmacy, or a related discipline is required. A Masters/Post Grad qualification in Regulatory Affairs is preferred but not essential.
* At least 2 years experience working in a regulatory affairs position within a regulated pharmaceutical environment is required.
* Experience working with US regulations and submissions is required.
* Experience in regulatory publishing tools would be an advantage but is not essential.
Our offices are based in Clonmel, Co. Tipperary, and we facilitate a flexible hybrid working policy where we alternate working from home for the majority of the time with regular visits to the office for in-person interactions with your colleagues. You will also work closely with our commercial team and other colleagues who are based in the USA.
When joining Shorla Oncology, you will join a self-motivated and energetic team. Our success depends on our collaboration, camaraderie, teamwork, and team spirit. You will work in a hybrid manner and have opportunities to learn and grow your career. If this sounds like the characteristics of your ideal workplace and you want to work in an exciting growing fast-paced company, then we are a good fit for you.
We offer a competitive salary and an attractive range of benefits including a discretionary bonus scheme, private medical cover, employer pension contributions, generous annual leave, and opportunities for upskilling and career progression.
Shorla Oncology is an equal opportunities employer.
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