Job Details

Overview

We are seeking a Temporary CMC Regulatory Dossier Manager in Alameda, CA. The role focuses on authoring and managing the review and approval of moderate to complex CMC regulatory documents, including Module 2 and Module 3 submissions for development and post-approval dossiers, technical reports, and SOPs. The position offers a direct impact on the organization and the clinical industry.

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 for regulatory actions in both post-approval and development stages, 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 PSC working practices and procedures, and help update and maintain procedures and templates.
• Manage the document review process and schedule meetings to ensure documentation timelines are achieved, providing status updates to stakeholders.

Experience & Education

• BA/BS and 2-4 years of experience in medical/technical writing; or MS and 1 year of experience in technical (CMC) or regulatory writing.

To Be a Best-fit Your Strengths Must Include

• Knowledge of biotechnology/pharmaceutical sector.
• Substantial Chemistry, Manufacturing and Controls (CMC) knowledge and experience with Common Technical Document content templates and content expectations for IND/NDA/BLA/MAA and other regulatory documents.
• Strong organizational and planning capabilities; ability to manage time and resources to complete assigned work.
• Self-driven with the ability to deliver results that support departmental goals.
• Clear verbal and written communication; keeps management informed of potential issues in a timely manner.
• Collaborative teamwork and good interpersonal skills with the ability to consider differing views.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization providing global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. For more information, visit the Advanced Clinical website.

Regarding your application

Please note that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We appreciate the time taken to apply and will respond as soon as possible.

Location

Alameda, CA