A Regulatory Affairs Associate Director with over 13 years experience covering the entire submission process(for US, EU, and emerging markets), interacting with all functional areas throughout the drug development process for planning and resolution of issues, identifying and implementing technology and process changes in submission process, and managing of direct reports(priorities, work assignments, and development).
- Experience with various electronic publishing systems & tools
- Experience with all submission types across all regions except Japan
- Supported over 20 complex submissions across EU, US, and emerging markets regions
- Microsoft Suite of Tools(Office, Outlook, Visio)
- Experience with managing and working with staff local globally
- Track record of successful process reengineering resulting in significant cost reduction
- 6 Sigma/Process Excellence
- Excellent verbal and presentation skills
- Responsibilities include cold calling and following up interest with face to face calls, visiting previous clients to reestablish relationship, visiting current clients to understanding their business in depth and highlight the entire portfolio that the company can provide for them, write up orders, and ensure that orders meet customer’s expectations and timelines.
- Responsibilities included process creation/improvement/measuring of internal Regulatory Affairs and cross functional processes, root cause analysis/corrective action for internal and external Regulatory Affairs issues & inspection findings, designing & defining implementation plan for new submission process and organization in support of newly created Regulatory Affairs organization, defining the model for procedural documentation through out the global Regulatory Affairs organization, managing up to 6 contractors for various projects across Regulatory Affairs, assessing requests for & determining responsible Regulatory Affairs participants for cross functional teams, and acting as internal consultant for project teams to assist teams in identifying/achieving project objectives, identifying issues/resolutions, ensuring project deliverables were in - line with overall direction of the Regulatory Affairs organization.
- Procedural Document Harmonization Project to align 5 Regulatory Affair
- Interacted and lead cross functional teams in support of Procedural Document Harmonization Project
- Improvement of the Periodic Safety Update Report process to improve the metric reporting, root cause analysis, and implement a lean process
- Various presentations to senior management teams to present project updates/milestones and gain approval on implementation of project deliverables
- Managed 3 groups(Archiving, Publishing, Production) within the Global Regulatory Operations organization.
- Responsibilities included issue mitigation for submissions(such as document formating, placement of documents within eCTD structure, managing of hypertext strategy, schedule for delivery of documents, and aligning internal processes with external partners), process improvement(moving Regulatory Affairs from a paper submission & file based organization to an electronic based organization, increasing the productivity of the organization without increasing headcount), identifying and implementing technology improvements(eSignature capability, electronic file-room providing access to global Regulatory Affairs organization) resource and project planning.
- Increased electronic submissions from <10% to over >90% of total submissions(includes all regions except Japan)
- Worked with various functional areas for submissions, setting up standards for electronic submissions & documents, and various issue resolutions across various functional areas
- Converted 2 paper file rooms to a globally accessible electronic system
- Outsourced the Production function for a savings of over $1 million annually
- Implementation of eSignature capability for FDA submissions
- Managed the Production and Routine Publishing groups.
- Responsibilities included creating and implementing of the Routine Publishing group(this included defining scope of work for new group, gaining approval/acceptance from upper management through various presentations, defining how publishing tools/systems would be used to support effective/efficient publishing, creating processes for how publishing/review/production/dispatch would occur), expanding the types of submissions that the Routine Publishing group would handle without impacting time lines or requiring additional resources(initially only a few submission types were allowed through the process but this changed to included all submissions that were not major submissions), Aligning/consolidating 2 Production sites(included the aligning of processes within the Production sites and across the Regulatory Affairs organization), and planning and issue resolution for critical submissions(identifying timelines for functional area deliverables, raising issues and resolving issues to ensure critical submissions remained on schedule).
- Managed the consolidation of 2 Production sites into one
- Implementation of the Routine Publishing process which reduced the overall submission timeline and laid the ground work for moving towards 100% of submissions being published
- Worked with Functional Area authors to create standards for submission ready documents
- Converted various paper submissions types to electronic format( i.e. advertising submissions & annual reports)
Senior Dossier Analyst
- Responsibilities included managing the day to day operations of the Production group(included planning for the daily workload of submissions that were required to be dispatched each day, planning for emergency submissions, assigned work for temporary staff each day), managing all Production activities for critical submissions(creating internal timelines for meeting project milestones, ensuring daily targets were achieved, supervising all overtime resources), supply management to support critical submissions/high volumes periods/daily workload(required identifying required supplies 1 month out and ensuring they were ordered, delivered, unpacked, and ready for use when required), providing input to project plans for critical submissions and any other submissions requiring advanced planning(included attending project meetings and be content expert for Production), new temporary staff, and publishing submissions.
- Managed the creation of a new Production group area
- Transitioned paper distribution process to electronic distribution process reducing paper usage and time
- During this time handled daily submission work(about 10-20 submissions daily) and also supported critical submissions(about 15 critical submissions).