Manager, CMC Regulatory Dossier Management

Target PR Range: 100-110/hr
*Depending on experience

SUMMARY/JOB PURPOSE:

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 required
*CO/NYC candidates might not be considered