CMC Regulatory Scientist II

Qualifications: 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. Proficiency needed in MS Office programs (Word, Excel, Outlook).?
Responsibilities: 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.


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