Expert in designing and executing DMPK studies to support antibody-drug conjugate and monoclonal antibody programs, from discovery through IND-enabling stages.
Recruitment of study participants Collect, clean, process, and manage dataset from various sources Stay updated on new methods and tools in data science relevant to public health and biomedical research. Ensure data integrity, security, and compliance with regulatory standards. Channelizing the study protocol with other team members for completion of study. Reporting day-to-day activities to the study PI.
D.Pharm, B.Pharm with post- qualification experience in retail pharmacy. The selection process for the positions of Pharmacist, Assistant Pharmacist comprises of written test and interview.
Set and agree written goals and objectives, perform annual appraisal interviews and end of probation appraisals; submit promotion requests to management as appropriate. Ensure resource and recruitment are well aligned and timely managed in collaboration with relevant parties, participate in interviews for potential new hires.
First class post graduate degree, including the integrated PG degrees preferably bioinformatics, computational biology, computer science OR Second class post graduate degree, including the integrated PG degrees with PhD.
Aspiring interns should be in the pre-final or final year of their Masters M.E, M.Tech, M.Sc or Bachelors degree course B.E, B.Tech, B.Sc in India in Life Sciences, Biotechnology, that are relevant to the research projects at CBR.
The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective. Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures.
Candidate with project management experience in Discovery Sciences along with Commerical or Product launch, Product strategy experience would be preferred; should be adept at managing project milestones, budget and stakeholders.
The candidate will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. The candidate will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department.