Global Regulatory Affairs (CMC) Manager

Client: Direct Client

Location: Lexington, MA

Job Title: Global Regulatory Affairs (CMC) Manager

Duration: 5 Months + (Possible Extension)

Summary 

Under the direction of the Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing global CMC strategies across product life cycles & execution in North America. Provide collaborative support for execution of global strategies to other regions (EU & International). Manage submissions and interactions with the FDA and Health Canada for CMC issues. Provide support to other HA interactions as required. 

Job Function and Description: 

• Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned. 

• Manage preparation of US and Canada applications in a timely manner to meet corporate objectives. 

• Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives. 

• Develop global CMC regulatory strategy and manage regulatory activities and timelines for one or more investigational and marketed products 

• Collaborate with EU & International regulatory colleagues in development of global CMC regulatory strategies. 

• Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies. 

• Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.

• Provide CMC regulatory guidance to project / product teams. 

• Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.