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.
Bachelors or Masters degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline.
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
Perform analysis of raw materials and finished products using UV, IR, HPLC, UPLC, GC, LCMS, etc. Ensure adherence to SOPs, GMP, and ALCOA principles during shift operations.
Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents.
B.Pharm or Approved Diploma in Pharmacy from an institute recongnised by the Pharmacy council of India and registered as Pharmacist under the Pharmacy Act 1948
Masters in Natural or Pharmaceutical Sciences/ MVSc/ Animal Sciences OR degree in Engineering or Technology or Medicine from a recognized University or equivalent