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CMC Regulatory Scientist

? The major responsibilities include: preparing, revising and updating CMC sections and ancillary GMP documentation for of global Marketing Authorizations; ensuring that all regulatory documents are prepared accurately, completely and on-time; tracking project status and effectively communicating progress.
? Applicant will be responsible for multiple project assignments with critical timelines.
? B.S. degree in Chemistry, Pharmacy or Engineering related field.
? Minimum 3- 5 years Pharmaceutical CMC focused regulatory experience with most of the world filing emphasis.
? Global experience preferred.
? Applicant should have experience conducting regulatory assessments, submission authoring and assembly using CTD structure, and eCTD lifecycle management.
? Proven organizational skills and excellent written/verbal communication are required.
? Applicant should have demonstrated writing skills, attention to detail and problem solving skills.

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