Nancy Ryan Email & Phone Number

Develop and lead the execution of global regulatory CMC investigational and registration strategies for assigned products. Work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout the clinical development lifecycle. Plan and execute regulatory submissions for assigned compounds in several phases of clinical development.

• Effectively managed day-to-day activities of a global CMC regulatory team for a mature biosimilar product active in 39 markets
• Led CMC team remits including initial registration submissions, supplements, variations, commitments, annual reports, renewals, change control assessments, and responses to agency queries
• Developed regulatory strategy for post-approval change filings to ensure alignment with current regional/market regulations
• Provided global CMC regulatory leadership for large strategy development to ensure that compliance is achieved and sustained throughout the product’s lifespan
• Authored, reviewed, and approved Module 2 CMC sections and Module 3 sections and health authority query responses for project submissions including seven initial applications and forty-two post-approval submissions for.
• Participated in global matrix teams including the technical team, supply chain team, and manufacturing groups (internal and CMO)

• Promoted from CMC strategist to Leader of a global CMC Team Lead for a biosimilar product Feb 2021
• Reviewed and approved submissions supporting marketing applications, amendments, variations, annual reports, commitments, and responses to agency queries
• As CMC team lead, twelve initial registrations were submitted to markets including Canada and multiple post-approval changes and query responses were submitted to major and global expansion markets
• Managed submission timelines utilizing project trackers with detailed task assignments and critical path milestones
• Managed change control assessments for CMC regulatory impact

• Authored post marketing submissions to US for a biosimilar product
• Authored initial registration submissions for global expansion markets
• Authored post-approval submissions and responses to agency queries

• Managed the stability program for multiple biological products at early and late stage of development cycles including data review and statistical trending
• Authored and reviewed CMC sections for regulatory clinical and marketing application submissions (IND, NDA, and BLA), responses to Health Authority queries, and briefing documents
• Authored and reviewed technical documentation, i.e., stability protocols and reports, strategy documents, standard operating procedures, analytical methods, method validation reports and comparability reports
• Managed the internal review and approval process for both regulatory and technical documents utilizing project trackers
• Managed the authoring and review of batch analysis and stability sections for the BLA submission of a monoclonal antibody product with decades of stability study data
• Key contributor/participant for internal audits and health authority inspections

Authored CMC data tables for Module 2 and 3 CTD sections for regulatory submissions. Created and maintained tracking spreadsheets for work progression.