ROLE
– Compile, prepare, review and submit IND, NDA and ANDA submissions along with associated Amendments to FDA
– Develop and implement CMC regulatory strategies for IND/NDA and ANDA submissions, lifecycle management, and deficiency responses
– Maintain full awareness of all regulatory activities on assigned projects and ensure that project deadlines and performance standards are established and met
– Ensure high quality, compliance-driven submissions aligned with cGMP, ICH, and FDA expectations
– Prepare and finalize controlled correspondence as well as Pre-submission meeting package to FDA on specific issues as needed
– Ensure timely submission of all assigned projects
– Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency
– Evaluate post-approval change controls and formulates strategies for correct filing categories
– Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS
– Proactively raises major project issues to superior for resolution and agreement
– Evaluate final compositions for IIG and Proportionality similar criteria’s and develop regulatory strategies
– Review the API DMFs thoroughly and share the review comments to purchase department on-time

REQUIREMENTS
– Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects
– Excellent written and verbal communication skills and interpersonal skills
– Prior experience working with ANDAs, INDs, NDAs and FDA correspondences
– Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment
– Ability to communicate effectively and collaboratively as part of a team in a respectful manner
– Ability to interface with professionals domestically and abroad
– Ability to work independently, self-starter
– Working knowledge of ICH, FDA and 21 CFR regulations
– Good problem solving skills and analytical ability
– Aware of eCTD regulations and health authorities expectation
– Strong computer skills in order to learn new programs as quickly as possible
– Experience in MS Word, Excel, Power-point, Outlook and Adobe Professional