Strong knowledge of country-specific labeling regulations and guidelines across the US, EU, Canada, Australia, and Switzerland, combined with hands-on experience in label development, including CCDS, USPI, and packaging components.
Coordination with quality control department & quality assurance department for getting analytical data with respect to , process optimization batches & validation batches.
M.Sc. in the field of Biology, Molecular Biology, Human Genetics, Cell Biology, Biochemistry, Microbiology. Candidates with UGC-CSIR / NET / GATE / ICMR-JRF / DBT-BET qualifications will be preferred.
Knowledge of global and regional pharmacovigilance regulations. Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools.
Facilitate and manage corporate quality audits and regulatory audits and drive the Supplier Qualification Program, including the identification, evaluation through audits, monitoring, maintenance, and re-qualification of vendors.
Looking for dedicated professionals who are result-oriented, can assimilate, analyze and communicate data effectively and are excellent team players capable of working in a fast-paced, multi-disciplinary environment.
Bachelors Degree in life sciences or other related field required. Prepare and distribute status, tracking and project finance reports, and assist the project manager with budget allocation and approval of invoices.