CMC Regulatory Scientist

 
Location: West Point, Pennsylvania
Posted On: 8/11/2017
Job Code: PRV_1895_PA
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Job Description
 
Job Qualifications:
• B.S. degree in Chemistry, Pharmacy or Engineering related field
• Minimum 3- 5 years Pharmaceutical CMC focused regulatory experience with post- approval emphasis. Global experience preferred
• Applicant should have experience conducting regulatory assessments, submission authoring and assembly using CTD structure, and eCTD lifecycle management

Job Responsibilities:
• The major responsibilities include: preparing and updating CMC sections of global Marketing Authorizations; executing regulatory post-approval filing strategies and
variations for global products while 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.
Category:IT  code:new
 
 
Job Requirements
 
 
• 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)
 

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Recruiter
Paras Vadukar
 
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