Senior Regulatory Start Up Associate Novotech

3.0 - 7.0 years

0 Lacs

karnataka

On-site

As a Senior Regulatory Start Up Associate at Novotech, your role will involve planning, preparing, and reviewing country and site level ethics and regulatory authority applications and submissions during project start-up. Your responsibilities will include: - Serving as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) on allocated projects. - Providing expertise and guidance on country and local regulations, keeping abreast of developments and changes in regulations. - Working within the scope of relevant SOPs and ICH-GCP guidelines. - Providing country and site level information on submission deadlines and timeline metrics. - Ensuring compli...

Posted 2 days ago

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Senior Regulatory Start Up Associate Novotech

3.0 - 7.0 years

0 Lacs

karnataka

On-site

As a Senior Regulatory Start-Up Associate at the company, your primary responsibility will be to plan, prepare, and review country and site level ethics and regulatory authority applications and submissions during project start-up. Your role is crucial in ensuring compliance with ICH-GCP and local regulatory requirements to facilitate timely clinical trial approval. Your key responsibilities will include: - Serving as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. - Providing expertise and guidance to RSM and/or PM on country and local regulations and practices, staying updated on developments and chan...

Posted 2 months ago

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Apply

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