Katherine Hardwick Email & Phone Number

Boston, Ma

• Lead multifaceted project plans from project initiation to close out• Develops and manages regulatory submissions and Agency interactions, from early to late phase programs in gene therapy and small molecule products, utilizing FDA, EMA, and country specific guidance• Lead complex transitional plan to transfer sponsor of an active product• Facilitates the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements• Coordinates timelines, preparation, and logistics for FDA Agency Meetings• Generates and maintains status reports and other project related artifacts • Lead communication of project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed• Work with Global Regulatory Program Lead to create ad-hoc requests for project related information• Regulatory timing and cross-functional coordination expertise for the following Regulatory Applications and subsequent activities, including by not limited to, initial investigational (IND/CTA) and marketing applications (MAA/BLA/NDS/NDA), response to RSIs, lifecycle management and Agency interaction prep and logistics: EMA and US Orphan Drug Designation (ODD), US Initial INDs, EMA Initial CTAs, EMA Pediatric Investigation Plans (PIP), FDA Pediatric Study Plan and PPSR, EMA Priority Medicines (PRIME), US Regenerative Medicine Advanced Therapy Designation (RMAT), US Breakthrough Designation (BTD), FDA Rare Pediatric Voucher Request, US interactions with Controlled Substance Staff (CSS), EMA/CHMP Scientific Advice Meetings, EMA Oral Explanations, FDA End of Phase Meetings, FDA Pre-IND Meeting, Pre-Marketing Application Submission Meetings, Other FDA Meetings.

Boston, Ma

• Continued responsibilities of Administrative Associate II role• Helped maintain project dashboards for Submission Management Team• Worked with Regulatory Compliance & Process Management to provide consistent training curricula within Global Regulatory Affairs• Developed and maintained SharePoint sites for Global Regulatory Affairs• Provided administrative support for a drug product team• Assisted VP of Regulatory Policy & Operations with the management of departmental initiatives and projects

Boston, Ma

• Supported the Global Regulatory Affairs Vice President of Regulatory Policy & Operations• Arranged functional area meetings, provided agendas, and documented minutes• Provided logistical planning and administrative support (e.g. travel, expenses, scheduling, catering) for Regulatory Policy & Operations team• Ensured all departmental needs were met; such as, ordering office supplies, addressing concerns, and providing backup for other administrative associates

Boston, Ma

Braintree, Ma

• Identified potential students who would be good candidates for enrollment in University • Established relationships with students to ensure education and career goals aligned • Built pipeline of potential students to guarantee campus programs started with average of 10 students• Worked with departments to build successful class sequence to maintain student success and retention • Garnered enough student interest in the MBA program to offer it on the campus • Developed outreach strategy to recapture students out of attendance 365+ days which led to an increase of 2 students returning per month • Enhanced Community College outreach resulting in an increase of 10 referrals per college

Braintree, Ma

• Collaborated with C-Level to develop a role for the University that would drive outcomes and increase revenue • Developed a new student retention strategy to support students through their initial classes • Built relationships and trust with students for them to feel comfortable discussing any issues • Formed connections between different departments to ensure student success • Created all documentation needed within role • Saw 20% increase in first course completion at campus • Saw Student Satisfaction Survey average 50% higher at campus than University wide • Continued focus on SOPs • Worked with faculty to identify and solve student issues in the classroom

Lenexa, Ks

• Worked with team and C-Level to create outreach strategy to recapture students out of attendance 365+ days • Created spreadsheet utilized to track student enrollment progression from initial interest through 1st class • Identified and counseled potential students interested in returning • Developed a pipeline of interested students to maintain an average of 12 student starts per month • Assisted students with any paperwork or appeals needed • Collaborated with different departments to ensure student transition back into classes were seamless • Recognized and resolved any potential student issues

Kansas City, Missouri Area