CMC Regulatory Dossier Management Manager

The Manager, CMC Regulatory Dossier Management is responsible for converting scientific data into clear, scientifically sound, well-structured scientific, technical and regulatory documents intended for global health authorities and internal/external stakeholders. The job scope is focused on authoring and managing the review and approval of moderate to complex CMC regulatory documents, including but not limited to Module 2 and Module 3 CMC regulatory submissions for development and post-approval dossiers, technical reports and SOPs. ESSENTIAL DUTIES AND RESPONSIBILITIES:· Support the development of high quality, phase appropriate CMC-related submissions to health authorities by managing the authoring, review, and approval of regulatory documentation.· Coordinate the development of responses to health authority questions and documentation requests.· Ensure appropriate archiving of source technical documentation.· Track and manage external partner regulatory actions and supporting documentation associated with regulatory actions in both post-approval and development stage changes, through completion.· Ensure continued regulatory compliance and phase appropriate, risk-based approaches to manufacturing flexibility while adhering to change control procedures and health authority requirements.· Contribute to the development and maintenance of the PSC working practices and procedures, as well as help update and maintain procedures and templates.· Manage the document review process and schedule meetings to ensure documentation timelines are achieved, providing status updates as necessary to stakeholders. SUPERVISORY RESPONSIBILITIES:· No supervisory responsibilities· May direct work to a CMO, Consultant or 3rd Party EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:Education:· BA/BS and 2-4 years of experience in medical/technical writing; or MS and 1 years of experience in technical (CMC) or regulatory writing.Experience/The Ideal Candidate will have:· Minimum 5 years experience in the pharmaceutical or biotech industries. Knowledge/Skills:* Possess substantial Chemistry, Manufacturing and Controls (CMC) knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation. WORKING CONDITIONS:PSC/Alameda:· Environment: primarily working in office· Travel not requiredDesired Skills and ExperienceRoth Staffing is looking for a CMC Regulatory Dossier Management ManagerAll qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

Created: 2025-10-02