Job Description
• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents
• Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
• Participate in Global Regulatory Affairs project teams
• Maintain working knowledge of internal and external publishing standards
• Working knowledge of industry legislation and best practices
• Knowledge of regulations/guidelines governing regulatory submissions (eCTD, NeeS, paper)
• Notices when data appear wrong or incomplete, or needs verification. Distinguishes information that is not pertinent to a decision or solution.
• Compares observations or finished work to what is expected to find inconsistencies. Remains aware and takes care of details that are easy to overlook or dismiss as insignificant.
• Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems.
• Delivers products and services when and where the customer needs them. Explores options when unable to deliver a requested product or service, and pursues solutions until the customer is satisfied.
• 1-2 years in Regulatory Operations or 4-6 years in Regulatory Affairs.
Additional Information
Qualification : B.Pharm /M.Pharm, Bachelor in life sciences
Location : Navi Mumbai
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 15th April, 2019
