Sainte-Julie, Quebec, Canada
Work in pharmaceutical industry since 2015 (new drugs and generics). Quickly acquired development and regulatory knowledge and expertise to develop regulatory strategies (CAN and USA). - Aptitude to manage multiple projects, set priorities and meet deadlines. - Strong ability to identify gaps and propose or implement proactive solutions.
- Lead the development and review of responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter. - Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling. - Collaborate with global cross-functional teams and the Global Regulatory Affairs function/teams to facilitate regulatory activities. - Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals. - Develop effective working relationships with business partners and the authorities to support regulatory strategies. - Manage emerging issues new safety finding and the associated risk communications. - Provide regulatory guidance and input to internal partners on messaging, promotional material review, and PAAB responses. - Monitor the regulatory environment, interpret changes, analyze gaps and conduct impact assessment, and participate/lead implementation into systems/processes. - Actively contribute to the improvement of departmental processes and initiatives to enhance the internal work environment.
• Manages regulatory activities to obtain and maintain Marketing Authorizations for commercial products for FDA, Health Canada, EMA and other health authority regulations as applicable • Assists with the compilation, writing, review and submission of dossiers to regulatory authorities and ensures documents meet applicable regulatory requirements • Assists to provide regulatory guidance regarding the documentation and requirements for regulatory submissions • Assists to provide regulatory support and expertise for early phase clinical trials; pre-IND and clinical development meetings with regulatory Agencies; and the filing of IND/NDA/BLA and related submissions to FDA, EMA, Health Canada and other health authorities as applicable • Provides support to various partners, CROs and US/EU Agents to support registration of Theratechnologies’ product(s) and Market Authorizations in other territories/ countries; and liaises with the respective Health Authorities as needed. • Provides regulatory support and guidance to internal and external customers • Assists with/ coordinates the preparation of responses to questions and inquiries from health authorities; and subsequent follow-ups with regulatory agencies to maintain and update existing marketing authorizations • Analyzes product information, compiles and communicates annual notifications to Health Canada • Maintains current knowledge of relevant ICH, FDA, Health Canada, EMA and other health authority regulations as applicable Reviews and updates product labels, product monographs and labelling / packaging artwork • Assists with the preparation of DEL amendments, Annual Licence Renewals, Notifiable Changes, and PMPRB forms for submission to Health Canada • Prepares and reviews INDs, NDAs, BLAs, Annual Reports, and updates to Investigational Brochures to Regulatory agencies • Reviews reports and other regulatory documentation from Contractual Research Organisations (CROs)
• Maintain regulatory compliance for approved products (e.g. DIN, SANDS, annual notification - OTC, NHP, prescription drugs, medical devices). • Manages the preparation of eCTD files, including data evaluation, regulatory strategy and project coordination in a timely manner. • Ensures that scientific data in support of the submission, as well as daily regulatory activities are in compliance with Canadian regulations and all relevant policies and directives. • Review and approve product labels to ensure compliance with Canadian regulations. • Ensures an effective liaison with the partners of the company. • Provides regulatory advice to other divisions and/or departments (e.g. scientific affairs, operations, marketing).
• Manage and prepare regulatory fillings (ANDS, DIN and ANDA) for submission to Canada and US in the area of injectable drug products - Complete eCTD submission of DIN-A, actively participate in the review of currently approved ANDS and ANDA of ready-to-use injectable products • Assists with or executes the electronic publications and submissions (eCTD) • Manage and assess ongoing issues and Health Canada or FDA queries and manage response process in order to provide complete information • Assess Post-Approval Notice of Compliance Changes and file the change to the corresponding Agency when required • Prepare and revise drug product labels including the primary, secondary and tertiary components in order to ensure their conformity to the Product Monograph and to the applicable regulatory laws • Develop and maintain medical information; responsible to answer medication information requests and to communicate medical information to clients, patients and health care professionals; and transfer adverse events to pharmacovigilance department • Participate in the development, improvement and implementation of Regulatory Affairs processes and SOPs • Collaborate with development and engineering groups to ensure compliance with the regulations and standards (e.g. USP) and monitor project timelines • Prepare, participate and assist to Health Canada meetings (e.g. pre-submission meeting, request for reconsideration
• Manage and prepare regulatory fillings (ANDS, DIN and ANDA) for submission to Canada and US in the area of injectable drug products - Complete eCTD submission of DIN-A • Assists with or executes the electronic publications and submissions (eCTD) • Manage and assess ongoing issues and Health Canada or FDA queries and manage response process in order to provide complete information • Develop and maintain medical information; responsible to answer medication information requests and to communicate medical information to clients, patients and health care professionals; and transfer adverse events to pharmacovigilance department
• Conscientiously apply procedures established by USP and BP • HPLC Formation by Agilent Technologies (2015) • Executes analytical and physicochemical tests on pharmaceutical products and drug products as per the proposed approved specifications • Observe, assess and discuss issues of the sterilization method used on the drug product quality to ensure a high quality standard • Maintain a laboratory notebooks and R&D calendar for subsequent audits • Design and redact R&D protocols, SOPs and technical memos • Develop and proposed the prototype formulation as per the obtained results for the tech transfer • Carefully follow established procedures for handling and documentation of the use of narcotics