Consulting Position – Long Term 40hrs Week – Remote

Job Summary:

• Supporting the CMC Regulatory Affairs team in developing, coordinating, and implementing global CMC regulatory strategies for assigned programs and tasks
• Author/compile CMC sections of regulatory submissions
• Provide Reg CMC support for development programs to ensure that products are developed and manufactured in compliance with appropriate regulations and guidelines
• Translational Pharmaceutical Sciences: This innovation engine will practice rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield.
• Develop global CMC Core Dossier for Module 3
• 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.

Requirements:

• B.A. / B.A./ M.S. / Ph.D. in biochemistry, chemistry, biology, or related pharmaceutical field.
• Minimum of 10 years’ experience in pharmaceutical product development.
• Significant experience in CMC regulatory affairs with a strong biologics background or equivalent.
• Experience in directing interactions with regulatory authorities desired.
• Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.
• Significant coordination with cross-functional teams internally and regulatory authorities externally.

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