First Class Masters Degree in Pharmacology, Life-Sciences from a recognized university. Experience in the Research field and scientific writing. Candidates with proficiency in computer application will be preferred.
knowledge of various sophisticated instrumental methods for qualitative and quantitative analysis of tissue engineered constructs and regenerative technology development for clinical translation.
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.