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.
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.
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