Scale up & tech transfer, exposure of SDM qualification, process characterization and virus validation, Analyse experimental data, interpret results Documentation
A Ph.D. degree in relevant field such as pharmacy / life / chemical science or its equivalent, with published research papers in Science Citation Indexed journals.
Christian Medical College, Vellore, widely known as CMC, Vellore, is a private, Christian minority community-run medical college and hospital in Vellore, Tamil Nadu, India.
MSc in Biotechnology/Pharmaceutical Biotechnology / Biochemistry / Bioinformatics / Life Sciences or equivalent with 3 years teaching/research experience
The candidate should be M.Sc. in Zoology/Biochemistry/Life sciences with a first-class division at both the undergraduate and postgraduate levels. Additionally, the candidate must be a resident of Uttar Pradesh
Post Graduation in Science with P.G. Diploma in Clinical Research is Mandatory. Candidates with minimum 6 months experience in handling regulatory trials would be desirable.
The Clinical Project Leader is responsible and accountable for start-up and follow up on Registries in close collaboration with Registry Team and Medical Affairs staff in the countries or locally.
Executing chemical reactions in mg to gm scale and to synthesize required quantities of molecules/compounds as per client specifications using efficient route and techniques.
Responsible for the ordering and tracking of specific regulatory requirements such as registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorisation, Powers of Attorney, Translations of regulatory documentation
Candidate will be responsible for preparing and managing regulatory dossiers, coordinating with regulatory authorities for EU and ASEAN markets and providing guidance on regulatory requirements to internal teams