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| CMC Director MA Open (J#45484) Title: CMC Director Company: Ironwood Pharmaceuticals Description: To apply, send email with a subject of Job Code GRCDRA . Please include a CV and cover letter with your email message. Reporting to the Senior Director, Regulatory Affairs, the Director of CMC Regulatory Affairs will be responsible for developing and implementing CMC regulatory strategies as well as coordinating all aspects of CMC regulatory submissions. This person will develop the function of CMC regulatory within Ironwood as well as serve as the regulatory CMC representative on project teams. - Develop the function of CMC regulatory; - Develop and implement CMC regulatory strategies for investigational, and ultimately, commercial drug products; - Lead activities, including planning, writing and reviewing CMC (chemistry, manufacturing and control) sections of all regulatory submissions (INDs, NDAs, CTXs, meeting requests, and briefing documents) to support clinical trials and product registration. This will require the development and management of project timelines; - Coordinate the preparation of responses to regulatory agencies; - Act as primary regulatory representative at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues; More... | |||
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