Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.
Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures.
Exposure to OSD Manufacturing operations like Compression, Pellet coating, Capsule filling, Primary Packing & Secondary Packing. Expertise in e-BPR and e-log will be added advantage.