Manager / Senior Manager, Regulatory Affairs CMC

Location: Bay area, CA

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RBW have been engaged by a very exciting organisation based in the Bay Area of California that are looking to add a new member to their growing Regulatory team.

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With an approved drug already on the market, plus a number of Phase 2 and Phase 3 trials taking place, this organization are seeing some fantastic success as they continue to grow. This growth has led to the need to grow their Regulatory function by adding a Manager / Senior Manager of Regulatory CMC. This individual will be assisting with Regulatory CMC activities such as strategy and CMC submissions for projects in the US and globally.

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To be considered, we are looking for individuals with the following knowledge and experience:

• 7+ years pharmaceutical industry experience with minimum of 3 years of Regulatory CMC experience

• Experience preparing and managing high-quality CMC regulatory submissions for investigational and/or commercial products

• Have an understanding of small molecule CMC attributes and the development process of new molecular entities

• Solid knowledge of US regulations and guidelines

• Bachelor’s degree in a scientific discipline; advanced degree preferred (MS, PhD)

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If this sounds like the next step in your Regulatory career, please apply today so that Chris Sinclair at RBW Consulting can review your profile and be in touch to discuss this further.

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Salary: $160,000 - $185,000 Per annum