Prestige BioPharma (PBP) is a Singapore based biopharmaceutical company focusing on development of biosimilars and new antibody therapeutics. PBP has strong presence and networks in Asia Pacific region and actively penetrating into the global pharmaceutical market. The successful completion of phase I clinical trial on its first biosimilar HD201 (Trastuzumab) in EU, 2014, has placed PBP amongst the top-tier biosimilar developers.
With your combined knowledge of scientific, regulatory and business issues, you will mainly be responsible for assisting in European Agency (EU) regulatory matters, such as planning and executing activities necessary for product registration while complying with regulatory requirements. You will engage with external stakeholders and keep track of document lifecycle.
Targeted Students (the faculty/major of the intern):
- Holds a bachelor degree or working towards a degree in life science, pharmacy, biomedical science or equivalent
- Good knowledge of biologics regulations and ICH guidelines will be an added advantage
- You should be organized, meticulous, have an eye for detail, possess good analytical and problem-solving skills
- Excellent verbal and written communication skills is a must
- You should be able to work independently
Job/Internship Description (Duties to be carried out):
- Assist in compilation and submission of Electronic Common Technical Document (eCTD)
- Gain knowledge and experience in regulatory requirements for biosimilars
- Review documents to ensure regulatory compliance is met
- Liaise with both internal and external stakeholders to facilitate accurate information flow between departments.