Be a strong advocate for the Takeda ONE Oncology and R&D organizations in India in collaboration with India LOC; serve as local bridge for any future opportunities in engaging India innovation ecosystem.
Strong knowledge of GMP regulations including WHO, EU GMP, PICS, TGA, MHRA, USFDA & other global regulatory guidlines.
Expertise in handling CAPA, CCF, deviations, market complaints, product recalls if any.
Designs and coordinates the overall direction of clinical development projects. Coordinates activities of associates and investigators to ensure compliance with protocol and overall pre-clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings
Bachelors degree in life sciences, pharmacy, or a related field. An advanced degree is preferred. Extensive experience in pharmacovigilance or drug safety reporting, with a strong understanding of relevant regulations and guidelines.
BS degree in Pharmacy or Life Sciences or relevant education. Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.