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 related systems. Ensures harmony across all related systems• Established VEEVA as the single source of truth for tracking the status of all Study Information & Patient Programs, Company Offices, Corporate Sponsored Websites/Social Media, Marketed Product Information, Medical Information Contacts• Developed a method for reporting the linkage between CCDS versions and local label versions • Leads development of Regulatory processes and procedures to support company growth• Leads/oversees audit/inspection readiness activities related to Regulatory Affairs• Oversaw the submissions related to approvals, withdrawal from market and subsequent divesting of VARUBY/I tablet and IV formulations• Served as Head of Medical Writing, overseeing the development of Protocols, Investigator’s Brochures, Clinical Study Reports & Regulatory Summaries until Clinical Research leadership was hired• Oversee budgets and accruals for RA/QA

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• Designed and implemented a Regulatory Compliance function for surveillance and disposition of regulatory requirements• Managed 7-fold publishing workload with 0 increase in headcountDirector, RegAffairs (May 2011)• Submitted KALYDECO NDA/MAA, with FDA approval in only 3 months• Responsible for the role of Chief Archivist; managing the storage, tracking, and retention periods for all raw data, documentation, protocols, final reports, and specimens as per 21 CFR 58• Supported Business Development by supplying, managing and maintaining redacted document sets for multiple suitors• Designed and implemented Disaster Recovery and Business Continuity plans for the Regulatory DepartmentAssociate Director, Reg Operations (Sept 2010)• Responsible for the role of Chief Archivist; managing the storage, tracking, and retention periods for all raw data, documentation, protocols, final reports, and samples as per 21 CFR 58 and cGLPsSenior Manager, Reg Operations (March 2010)• Served as Dossier Manager/Lead Publisher for the VX-950/INCIVEK NDA and VX-770 KALYDECO NDA/MAA• Developed and led team with members of Med Writing, ClinPharm and Biostats to streamline the entire Clinical Study Report development process in support of granular filings• Conducted x-functional workshops pertaining to the creation, authoring, review and approval of submission documents and associated data

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• Managed distribution of controlled documents within the company and to outside vendors

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 pharmaceutical companies• 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• Converted MSWord labeling documents into Structured Product Labeling (SPL) format in conformance with current requirements• Converted eCTD submissions into paper format for clients required to submit both electronic and paper dossiers• Performed in-house product testing and evaluation• Author, reviewer and approver of SOPs, SOWs, UFRSs, CDAs, and responses to RFPs• Assisted in the CRT section creation including define.pdf and annotations to blank.crf files as per current regulations• Developed templates for authoring multi-regional eCTD sections

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• Implemented a method of sending secure electronic regulatory correspondence to CBER, develop ground rules and train on usage• Performed regular internal RA file audits

• 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, TMF, and department SOPs

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• Laboratory maintenance as it pertained to GMP,GLP, EPA, OSHA and Cubist specific standards - Including but not limited to: regulated badge access, on-site laboratory refrigeration monitoring and logs, fire extinguisher and safety inspection logs, general environmental management (lab and office temperature readings, water and boiler room monitoring)• Other duties as performed Glass-wash, Media prep, Radioactive and Biohazardous waste removal, MSDS archive, etc• Maintained catalog of off-site archive for all corporate records (All GXP files, IT backups, Marketing, HR, Finance, Legal)