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The position is responsible for managing regulatory activities of R&D and/or lifecycle submissions to US FDA. This includes, but is not limited to the compilation, review and submission of pre-approval (R&D) and/ or post-approval (lifecycle) submissions, such as original applications, amendments and deficiency responses, annual reports, supplements, supplement deficiency responses, and general correspondence for all regulatory submissions with a focus on Chemistry, Manufacturing and Controls (CMC) and Labeling. The candidate will be required to provide regulatory support in applicable project team meetings. The candidate will be expected to meet all submission timelines to ensure timely and quality submissions to support the business.
Core Job Function:Compiles, reviews and submits applications, amendments and/or lifecycle changes (focus on CMC and Labeling) for the US market. Regulatory submissions such as annual reports, supplements, amendments for ANDAs and NDAs will be submitted to FDA as per the business needs and compliance with all FDA requirements.
Technical review:Reviews change controls for regulatory impact and documentation to be included in regulatory submissions (i.e. batch records (manufacturing, packaging), specifications, analytical methods, etc.)
Cross-functional interaction:Work closely with cross-functional departments (i.e. Quality Assurance, Quality Control, Technical Services, Product Development, Analytical Development, Project Management etc.) to provide the appropriate regulatory requirements/guidance, as applicable. Support will also be provided to cross-functional teams for applicable submissions to US FDA.
Processes and procedures:Assist in the development and/or improvement of regulatory best practices, processes, and procedures.
QualificationsBachelor’s degree required Bachelor’s degree in scientific-related discipline preferred 2-5 years of regulatory submission experience Excellent verbal and written communication skills Ability to multitask Ability to manage timelines and priorities Ability to work independently with some guidance Attention to detail Critical Thinking
Functional Competencies:Thorough understanding and working knowledge of regulatory requirements for pre-approval and/or post-approval submissions for the US Market. Good understanding of regulations and requirements for US market through working knowledge, FDA Guidance Documents and MAPPs, ICH Guidelines, Code of Federal Regulations as they pertain to generic drug products. Demonstrates the ability to ensure high quality submissions to US FDA.