Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Sandoz
Ensure assigned products remain in a validated and compliant state as per MS&T and regulatory expectations. Contribute to investigations and prepare OPV reports, PPQ documentation, regulatory responses, and scale up proposals.
Provides support according to the needs for delivery activities, i.e. co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.
Review and assess local country labels to identify deviations from the core labeling and propose topics for further cross-functional assessment during the periodic core labeling review process
Sandoz opening as Scientist - Pharmaceutical Development. M.Pharm or PhD can apply at Telangana plant for document scientific experiments /GMP testing /manufacturing plant activities
Experience in IT, healthcare, or pharma; expert understanding of technology and methodologies as applied in the respective area. Good experience in technical planning, system integration, verification and validation, evaluating alternatives including cost, risk, supportability and analyses for systems total cost of ownership
Pyzchiva is a key biosimilar value driver for Sandoz, contributing to the company’s overall growth strategy. The company ranks number one in biosimilars globally and across key markets in Europe. The commercial availability of Pyzchiva, which builds on the US launch of Hyrimoz in July 2023, marks an important step in the Sandoz strategic ambition to become number one in biosimilars in the US.
Interpret and compile external supplier APQR and or extracted data from Internal Sandoz systems into a pre-defined template and draft conclusion of product quality review.
Plan, implement and evaluate experiments for establishing of composition, manufacturing procedures and packaging via support of def. evaluation experiments taking product stability, bioequivalence and possible production site into consideration.
Plan and execute experiments in agreement with quality risk management and GDevP, GMP -Assists in the preparation of and reviews of the technological part of dossier