Hyderabad

Exploring how Theileria parasites repress host gene expression PARA- REPRESS. Post Graduate Degree in Natural Sciences with experience in research and development in industrial and academic institutions or Science and technology organizations. Candidate with experience in epigenomics, cancer biology, molecular biology, cell culture, and bioinformatics will be given preference. 

Design, plan and perform scientific experiments for projects at different clinical phases of drug substance and drug product with minimal guidance. Well versed with regulatory guidelines, scientific literature, technology transfer and interpretation of the results to draw conclusions in reports.

Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA, Food and Drug Administration and EMA, European Medicines Agency, and SOPs/ QDs. Review study team-developed documents as per SOP, such as study id card, protocol, amendments, WSI, eCRF Case Report Form and completion guidelines, Centralized Monitoring Plan, committee charters and or other operational documents as requested to provide operational input.

Conducting and coordinating clinical trials in the department of Medical Oncology. A phase I, Ill, randomised, double blind, multicentre, parallel arm, clinical study comparing the efficacy, safety, immunogenicity and pharmacokinetics of proposed biosimilar nivolumab with nivolumab reference medicinal product.

B.Sc./ B. Pharmacy /M.Sc. M. Pharmacy; Preparation and review of Standard operating procedures Retrieval of BPCRs in case of batch cancellation, planning changes. Handling and Execution and investigation of QMS documents in change controls, deviations, and CAPA.

Hetero Drugs is an Indian pharmaceutical company and the worlds largest producer of anti-retroviral drugs. Heteros business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.

ANNORA Pharma is committed to provide medicines with highest quality, safety and efficacy that meets the needs of the customers with applicable statutory and regulatory requirements.

Sound knowledge of analytical method development and Method validation using HPLC as per guidelines. Knowledge of calibration and operations of all equipment like balance, ph meter, in analytical operation.

Provides the labeling, artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides strategic labeling input and support for global development projects and, or marketed products