Consulting Position – Remote

We have a newly created long-term CMC Regulatory & Quality consulting position. In this role, you will provide CMC Regulatory guidance and strategic support to clients and teams, ensuring that regulatory submissions and documentation are accurate and compliant with relevant regulations, guidelines, and industry standards.

Responsibilities:

• Author/compile CMC sections of regulatory submissions
• Research and apply current regulatory expectations relating to manufacturing, analytical methods, stability, and supply chain controls.
• Assist in managing CMC development projects.
• Assist in the preparation of study protocols/reports, specifications, analytical methods, batch records, and other technical documents supporting CMC development.
• Assist in the selection process for contract manufacturing/laboratory vendors to support client programs.
• Assist in the creation and execution of phase-appropriate Pharmaceutical Quality Management Systems to comply with applicable cGMPs.
• Review, assess, and/or analyze CMC development data/information to draw conclusions and/or formulate strategies to progress product development.
• Process, publish, and review electronic regulatory submissions in eCTD format.
• Perform quality control review of technical aspects of regulatory submissions and critical review of submission components to ensure technical completeness of submissions.
• Provide support to colleagues in the other practice areas, including clinical, nonclinical, regulatory, and quality.

Requirements:

• Bachelor’s degree, preferably in a scientific field (e.g., biology, chemistry, biochemistry, etc.). An advanced degree is desirable.
• A minimum of 5 years in the pharmaceutical/biotechnology industry and consulting with at least 3 years in CMC Regulatory Affairs.
• Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
• Experience with CTD format and content.
• Ability to work independently and within a group setting and to interact effectively with different functional areas.
• Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
• Strong computer skills using MS Word, Excel, and PowerPoint.

#remote #contractor #contracting #cmcconsultant #regulatorycmc #cmcdevelopment #qualityconsultant #lifesciences #biotech #pharma #medicaldevice #qms #qualitymanagementsystems #cgmp #gmp #regulatorysubmissions #regulatoryaffairsrecruiter #manufacturing #analyticalmethods