Head of the global publishing organization with sites in the US, UK, Germany, India, Australia and New Zealand responsible for delivery of the Viatris portfolio of products spanning its many different therapeutic categories and dosage forms.

Core Competencies:• Global Regulatory Operations & Affairs specifically Submission Planning and Publishing of Simultaneous Electronic Submissions (eCTD, NeeS) including IND's, BLA's, NDA's & MAA's and all associated maintenance and compliance submissions and HA Responses.• Planning and implementing complex regulatory filing strategies to ensure success and expedite time to market using sound understanding of global regulatory requirements.• Project managing complex regulatory… Show more Core Competencies:• Global Regulatory Operations & Affairs specifically Submission Planning and Publishing of Simultaneous Electronic Submissions (eCTD, NeeS) including IND's, BLA's, NDA's & MAA's and all associated maintenance and compliance submissions and HA Responses.• Planning and implementing complex regulatory filing strategies to ensure success and expedite time to market using sound understanding of global regulatory requirements.• Project managing complex regulatory dossiers for multiple markets simultaneously ensuring optimal resource utilization and content reuse wherever possible.• Identifying and implementing high impact process changes upstream into the submission production process to prevent late stage rework and improve the overall submission process.• Building and Leading Elite Submission Production Organizations on and offshore• Global Submission Requirements including CDISC & Data Standards• Health Agency Meetings and Interactions; FDA Advisory Committee Preparation & Execution• Regulatory Intelligence Collection & Verification• Regulatory Program/Project Management (PMO)• Cross-Functional Team Leadership• Business Process Outsourcing• Global Resource Management, Talent Identification & Development• Continuous Process Improvement• KPI Design & Delivery Show less

Head of US Submission Production team responsible for the planning, publishing, quality and delivery of GSK’s global investigational and marketed pharmaceutical portfolio, including in-licensed products.Led the direction & development of 15 staff across multiple sites. Responsible for training, mentoring, coaching and career guidance of the team. Dotted line responsibility for UK and China publishing teams.