(Biogen Spin-off Company)Global regulatory lead for commercially approved biologic products

• Supported the authoring of CMC sections for initial commercial submissions, facilitated responses to health authorities during review, supported inspections, and managed post-approval change submissions (US, Canada, Australia/New Zealand & Japan)• Assisted in initial authoring of an EU MAA• Managed initial MAA submissions, query responses, as well as subsequent post-approval changes for multiple global emerging markets• Facilitated a cross-functional regulatory project team• Acted as the CMC primary lead on a project to develop a new state of the art registration management system which encompassed both tracking of registrations as well as change controls in one system• Managed IND/IMPD for ongoing clinical trials

• Responsible for providing Global Regulatory support for ongoing and future clinical trials, and life-cycle management initiatives• Support IND/global CTA's (original, amendments, annual reports) and BLA/MAA activities• Facilitate and manage responses to health authorities' inquiries • Primary regulatory contact to CRO for 6 active trials• BLA project management• Gather regulatory intelligence• Support batch release and regulatory approval of expiry assignments• Assess regulatory impact for manufacturing changes

• Responsible for multiple clinical biologics programs• Provide CMC Team representation for the Quality Unit• Authoring and quality review of CMC sections in regulatory submissions (IND, IMPD, responses, etc.)• Manage drug substance / drug product specifications• Review and approve major/critical manufacturing and/or laboratory investigations (deviations, OOS, cross-site and cross-functional)• Oversee product specific change control for clinical products (QA approval)• Define and review product specifications and specification changes for clinical products.• Oversee method transfer protocols & reports for clinical products (QA approval)• Perform prospective release and stability data trending – alert Quality organization about potential issues and evaluate remedial actions• Provide frontline regulatory and due diligence audit support• Participate in technology transfer activities which include transfer of manufacturing processes and analytical test methods • Participate in Materials Review Board meetings to represent major discrepancies associated with clinical products to facilitate the final disposition decision• Technical expert on the assigned product/process for Quality

• Responsible for six clinical stability biologics programs (DS, DP and reference material)• CMC Team representative for Stability• Represent the stability group on product task force meetings • Design, write, and execute stability protocols.• Analysis, review, and trending of data from ongoing stability studies• Reference material dating, and expiry/re-test period dating/extensions, for DS and DP• Author interim/formal reports, technical reports, and stability sections of regulatory filings• Provide stability assessments in support of shipping excursions, change controls, and investigations (OOS and AR)

• Responsible for products in the commercial Stability Program (DS, DP, and reference material) and product line extensions• Facilitate and present to the Stability Review Group and Specification Review Committee• Represent the stability group on product task force meetings• Design, write, and execute stability protocols• Analysis, review, trending, and reporting of data from on going stability studies• Reference material dating, and expiry/re-test period dating/extensions, for DS and DP• Author interim/formal reports, technical reports, and stability sections of regulatory filings• Provide stability assessments in support of shipping excursions, change controls, and investigations (OOS and AR)

• QC release, stability and validation testing utilizing PCR techniques • Data analysis and assay validation using validation spreadsheets and LIMS• Writing and revising documents

• Routine product testing (bioburden, LAL, growth promotion, biological indicator, PH, etc) and Environmental Monitoring (air viable, total particulate, rodac, etc.)