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.
• 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. It will combine translational research with pharmaceutical sciences and devices and will receive inputs from and into clinical research and manufacturing sciences.
• Develop global CMC Core Dossier for Module 3.
• Precision Medicine: This innovation engine will focus on developing comprehensive, value-oriented healthcare delivery packages around drug products targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine will drive innovation by practicing patient-centric R&D.

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, including 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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