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You will be a contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE
Define and lead the execution of global regulatory CMC strategies for device & combination products to ensure successful approvals in key markets and Compliance throughout development and lifecycle. Performs risk analysis for determination of probability
You will play a central role in guiding studies from planning through execution, ensuring timelines, quality, and compliance standards are consistently met. This role suits someone who thrives in a fast-paced environment, remains steady under pressure,
Work with the Global Regulatory Lead and Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regulatory documents include (not limited to),
You will be responsible for defining and implementing the regulatory pathway, from early strategy through to dossier submission, working closely with CMC, Clinical, Medical, and Quality teams. Define and implement the global registration strategy (Main