Patricia Thomas Email & Phone Number

Cornwall, Ontario, Canada

• Will prepare, review and coordinate regulatory submissions (MoH, FDA, EU, EC, additional special national local applications if applicable), in alignment with global submission strategy. • Develops and implements local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.• Will be primary contact for investigators and for the local regulatory to ensure submissions are managed in a timely manner.• Act as a key-contact at country level for all submission-related activities and participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.• Ensures alignment of submission process for sites and studies are aligned to the critical path for site activation.• Prepare the regulatory compliance review packages, as applicable, as well as liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.• In addition, develop the country and sites specific Patient Information Sheet/Informed Consent form documents.

DRUG REGULATORY AFFAIRS: •High level of technical knowledge of Canadian and international requirements as well as internal local and global processes, systems and standard operating procedures•Planned and conducted all activities related to the preparation, review and production of all types of submissions (i.e. CTAs, NC, Level III & IV In-House updates, Administrative NDS, annual DIN, etc)•Executed all activities related to eCTD submissions (building, publishing, hypertext linking), lifecycle management of dossier (sequences) and documents (attributes) •Ensured quality of all submissions in compliance with Health Canada, ICH and corporate guidelines•Interacted, consulted and collaborated with internal colleagues (regulatory, clinical, foreign markets) and key external customers (CROs) on policy and regulatory guidance requirements •Developed and executed continuous improvement processes to optimize departmental effectiveness and efficiency•Provided site, account and data management of local and corporate databases, systems, and applications to support departmental business objectives (i.e. eCTD shared drive, ISI, GDMS, GRS, IRIS, BRIO, eCCNET, Rosetta, Impala, Clinicopia, Clinphone, CSDS and LAN, etc). Lead and optimize local Product Monograph process•Lead the quality review and approval of Investigator Initiation Packages and initiated drug release for study start-ups in Canada. Ensured timely filing of the Clinical Trial Site Information Forms (CTSIFs) to Health Canada.•Responsible for the timely review and approval of country related submission packages (US and Canada) in accordance with ICH, GCP and all applicable regulations, laws and other ethical and quality standard guidelines.•Ensured the review and finalization of site specific Informed Consent forms in accordance with site and corporate specifications.•Responsible for the update of the clinical trial databases (CTMS), and for clinical supply and non-clinical supply management.

EXECUTIVE ADMINISTRATION• Over 22 years of executive level administrative support experience• Experience as a Personal Assistant requiring a high level of discretion, capability and organization; managed personal bills, bank account transactions, household issues and staff• Handled a wide range of office responsibilities such as: travel management, expense reporting, event planning, meeting and conference scheduling, corporate sponsorship and donations, trademark applications and renewals, operations and project cost tracking, budgeting and forecasting, corporate car and credit card program, as well as regular day to day administrative activities