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
Should have completed D.Pharm or B.Pharm Coures from any recognized educational institution. Should have registered with State Pharmacy Council. Primary Health Centre
M.Pharm / MS Pharm / M.Tech. / M.Sc. with specialization in Medical Devices/ Biomedical Sciences/ Chemistry / Electronics / Biotechnology / Material Sciences / Nanoscience / Nanotechnology or equivalent.
M.Pharm ; M.Sc. in Pharma, Life Sciences, Biotechnology, Biochemistry,Food Technology. Institute of Himalayan Bioresource Technology, Palampur is one of the National Institutes under the Council of Scientific and Industrial Research
D.Pharm or B.Pharm Course from any recognized educational institution. Must be registered with State Pharmacy Council under the newly established Primary Health Centre
Masters/ Integrated Masters in Natural or Pharmaceutical Sciences/ MVSc/ Animal Sciences OR Bachelors degree in Engineering or Technology or Medicine from a recognized University.