Demonstrated understanding of pharmaceutical manufacturing, analytical testing, and quality assurance. managing CMC Regulatory submissions for small molecules/vaccines/biologics
Knowledge on cancers of the haemopoietic lineage. Collaborate closely with clinician colleagues and other investigators to explore novel therapeutic targets and strategies for cancer treatment.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance, regulatory database entry and reports. Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information Management System.
GPAT is a national level examination for award of scholarship to qualified candidates seeking entry into Master of Pharmacy (M. Pharm) course. The first GPAT was conducted in the year 2010 and thereafter it is conducted every year till 2018 by All India Council for Technical Education (AICTE) as per the directions of Ministry of Education, Government of India and from the year 2019, the examination is conducted through the National Testing Agency (NTA) as per the directions of Ministry of Education, Government of India to till 2023.
Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.