Sean Mcniff Email & Phone Number

Boston, MA, US

• Member of the Global Regulatory Affairs Leadership team
• Managed the authoring, submission and approval of the ZEJULA NDA/MAA, priority/accelerated review
• Lead and develop Regulatory Operations and supported development of Medical Writing, PV Operations
• Created and implemented a global strategic plan for internal and outsourced resources and infrastructure for operational management of all regulatory documents, submissions/ archiving
• Provides regulatory project planning for all submission types, including leading cross- functional teams focused on identification, planning and execution of global regulatory submissions
• Functional owner for all regulatory systems, including electronic document management, commitment tracking, registrations planning and tracking, Pharmacovigilance System Master File, Regulatory/PV intelligence and.

• Senior Director, RegAffairs (July 2013)
• Member of the Global Reg Affairs Leadership team
• Designed and implemented a complete Regulatory Product Information Repository, with integrated registration planning, tracking, submissions, correspondence and commitment management in one interface
• Designed Core Competencies and Roles & Responsibilities for regops
• Oversaw the implementation of Regulatory Operating Plans with cross-departmental systems integration, including R&D and commercial program management
• Served as co-chair on various Quality Leadership Teams

• Manager, Regulatory Operations
• Assisted the program teams in the planning, execution, and delivery of submissions (across five active projects) to the regulatory authorities, including two INDs in eCTD format, Orphan Drug applications to US and EU
• Implemented an electronic gateway (ESG) for transmission of electronic submissions directly to FDA
• Managed/maintain relations with vendors who support regulatory filings
• Implemented eCTD authoring templates and trained authors on usage
• Created/ maintain an electronic system to track all regulatory communications

• Manager, Regulatory Affairs Professional Services Group
• Project lead for planning preparations, publishing, tracking, XML backbone compilation and validation for various electronic submissions (including NDAs, BLAs, aNDAs, INDs in eCTD format) for big and small.
• Managed Regulatory Services teams, per project
• Worked directly with FDA on various SPL projects
• Performed product demos, software/ process training for clients and new employees
• Developed work processes, styles guides and checklists for various publishing tasks

• Regulatory Operations Specialist
• Implemented and maintained the electronic publishing environment including configuration, software upgrades and validation
• Assisted in planning, preparation, tracking and compilation of all documents related to PANVAC-VF BLA in eCTD format
• Assisted the program teams in the planning, execution, and delivery of submissions to the regulatory authorities, including IND Safety Reports, eCTD pilot and EOP3 meeting Package
• Developed eCTD template suite and training tools for publishers and authors and implemented usage.
• Managed/maintain relations with vendors who support Regulatory Filings

• Organized, catalogue, track and maintain all regulatory documentation related to pipeline of vaccine development. Overhaul and maintain hard and electronic copies of all critical correspondence
• Published regulatory submissions to government agencies including INDs, IND amendments, BLAs, CTDs
• Provided assistance to the department in the research and justification and implementation of a validated software package for all electronic submissions to federal agencies
• Created and maintain an electronic system to track all regulatory and clinical communications, FDA correspondence, submissions, INDs, BLAs, reports, e-mails, memorandums, document templates, investigator brochures.

• Regulatory Associate, Regulatory Affairs
• Published all Regulatory submissions to government agencies including INDs, IND amendments, and a successful NDA (CUBICIN) under priority review
• Maintained archives for RA, GCP and GLP documentation
• Provided Regulatory intelligence/guidance updates
• Reviewed/approved all drug shipment packagesMaterials Coordinator, Facilities
• Certified (RCRA and DOT) shipper/receiver of hazardous materials and waste