Relevant experience in Quality Control Lab, Hands on experience in handling various instruments like (HPLC is must),GC,KF. Knowledge of GLP, GDP and lab safety, Awareness of Quality-QAMS, LIMS software.
Join Novartis as a Regulatory Writer and contribute to high-quality clinical and safety documents supporting global drug submissions. Ideal for candidates with medical writing experience.
Capable to handle analytical method development, Implementation, Validation as per requirement. Should have experience of Analytical method transfer to QC.
Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets
Clinical batch data review, method validation, and stability study evaluations as per cGMP & regulatory norms. Routine analysis of clinical samples and stability samples.
Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
Maintain effective relationship with the end stakeholders medical scientific community within the allocated Global Business Unit and product – with an end objective to develop education and communication content as per requirement
Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines and Extend support for any other Regulatory related Function.