Grace Hill

Over 15 years of pharmaceutical industry experience. Regulatory Project Manager with a strong track record of success in managing complex projects including submissions to health authorities and system implementations. Expertise in planning, overseeing and executing regulatory project timelines and deliverables, ensuring compliance with U.S. and international health authority regulations and guidelines. Expert at process mapping, streamlining end-to-end submissions process to health authorities and implementing document management, and publishing systems (Veeva RIM).

GH Consulting LLC                                                    Jul 2022 – Present

Regulatory System & Process Consultant (Veeva RIM)

Develop strategies and provide creative problem-solving solutions for end-to-end Regulatory submissions process to health authorities, increased efficiency of Regulatory electronic systems infrastructure and related R&D source systems, across multiple R&D functions to enable maximum use and value of Veeva systems on the same platform.

• Develop and implement project plans, defining scope, objectives, requirements, deliverables, and milestones, ensuring adherence to project timelines and budgets
• Develop standards, business processes, procedure documents and best practices for Veeva RIM
• Map processes and conduct gap analysis for end-to-end submission process to health authorities
• Led implementation of Veeva Publishing module and provide subject matter expertise on RIM related projects regarding Regulatory Operations and Publishing processes
• Provide business support for all new and existing RIM technology, including troubleshooting issues, systems and process training, and business administration
• Support system validation activities by executing test scripts for systems that support RIM processes
• Liaise with system and service vendors
• Collaborate with the Digital team and key stakeholders to continuously drive improvements
• Monitor and track new functionality and enhancement requests with each new release of RIM

Nektar Therapeutics, San Francisco, CA                 Apr 2017 – Jun 2022

Director / Associate Director, Regulatory Operations                                                     

Managed day-to-day regulatory operations functions and personnel. Led regulatory operations strategy and planning of major filing activities including INDs, NDAs, BLAs and maintenance of system infrastructure and processes to support electronic submission filings as required by health authorities.

• Led cross-functional teams for company-wide implementation of Veeva RIM and publishing integration 
• Developed and implemented project plans, deliverables, and milestones ensuring adherence to project timelines and budgets. This included collecting user requirements, working with external vendors, mapping end-to-end processes, and other project deliverables such as supporting configuration, validation, document migration, and end-user training. 
• Prepared annual department budget, authorized expenditures and tracked project costs
• Regulatory business owner/administrator and SME of Veeva RIM system and eCTD publishing software 
• Developed standards, business processes and authored SOPs and work instructions that supported publishing and DMS usage
• Responsible for recruiting, mentoring, development, performance review and feedback of five direct reports and two contractors

Actelion Pharmaceuticals, Inc., South San Francisco, CA       Aug 2011 – Apr 2017

Senior Manager / Manager, Regulatory Systems and Operations 

Managed day-to-day regulatory operations functions and personnel. Led regulatory operations strategy for commercial organization and planned major filing activities of commercial drug launches and maintenance submissions to FDA Office of Prescription Drug (OPDP). 

• Developed and implemented project plans, deliverables, and milestones ensuring adherence to project timelines and budgets. This included collecting user requirements, working with external vendors, mapping end-to-end processes, and supporting configuration, validation, document migration, and training. 
• Prepared annual department budget, authorized expenditures and tracked project costs.
• Led cross-functional teams for implementation of Veeva PromoMats and in-house publishing capabilities 
• Responsible for recruiting, mentoring, development, and performance review of three direct reports

Gilead Sciences, Foster City, CA                            May 2002 – Aug 2011

Regulatory Affairs Associate II (2007 – 2011)                                           

Promotional Review Committee (PRC) Coordinator responsible for the process management of promotional materials and submission of Form FDA-2253 for two of the largest selling drugs in HIV. 

Regulatory Operations Assistant (2004 – 2007)                                        

Coordinated and prepared meeting materials for business project team and steering committee meetings, and organized user demonstrations. 

Clinical Research Assistant (2002 – 2004)                                                 

Tracked and updated project timelines and liaised with internal and external departments as needed to assist CRAs in preparing protocols, study reports, and investigator brochures for submission to regulatory agencies. Assembled and distributed Investigator Brochures and study binders to clinical sites and updated investigator information in database

Astellas Pharmaceutical (formerly Yamanouchi Pharmaceutical), Palo Alto, CA          1996 - 2002

Marketing Manager

Managed all marketing communications activities, directed creative services and negotiated contracts with outside services and contractors.  Prepared annual department budget, authorized expenditures, and tracked project costs

Bachelor of Science degree, Business Administration, University of South Carolina, Columbia, SC Clinical Trials Design & Management Certification, UC Santa Cruz Extension, Cupertino, CA