Job
Description
Responsible for developing and implementing CMC regulatory strategies for assigned products in accordance with global regulations and guidances; and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of all regulatory milestones for moderate to less complex projects through the product lifecycle including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects. Lead execution of CMC documentation including IND/CTA, NDA/BLA/MAA, postapproval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Experience in reviewing scientific information and assessing whether technical arguments are clearly presented, and conclusions are adequately supported by data. Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills. Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance). Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, and interpersonal skills. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Required Skills: Adaptability, Adaptability, Business Processes, Communication, Communication Management, Detail-Oriented, Document Coordination, Electronic Common Technical Document (eCTD), Employee Training Programs, Financial Statements, Interpersonal Relationships, Management Process, Manufacturing, Mentorship, Project Management, Regulatory Affairs Compliance, Regulatory CMC, Regulatory Communications, Regulatory Compliance Audits, Regulatory Interpretation, Regulatory Research, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Risk Management and Mitigation {+ 4 more} Preferred Skills: Job Posting End Date: 06/13/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
