Manager - New Product Development International

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for leading Regulatory Affairs individuals accountable for management of new product registration activities in international markets that include compilation, review & submission of new product registration dossiers, deficiency responses and pre-launch variations etc. Perform due diligence and help cross-functional teams in planning, prioritizing & tracking of planned dossier dispatches/submission and launches respectively. Also responsible for Global Regulatory practices to manage regulatory information in various databases and ensure consistent practices and compliance is maintained at Global Apotex sites. This is to be accomplished by planning and managing the activities of the group. Establish strong linkages with R&D, Quality, Operations and the Regulatory Market Affiliates/Customers (LATAM, APAC, Caribbean, EMEA, GCC, EU and AUS-NZ market) and Regulatory partners at Global Apotex sites. Implement department-driven projects & support to set up new processes (as applicable) within team and ensure smooth transition & functioning. Responsible for coaching team members via sharing of technical knowledge/expertise. Job Responsibilities Schedule and assign projects to Regulatory Affairs team to ensure business timelines are met. Review, compile and dispatch new product submissions and pre-launch variations. Handling of deficiencies received from Affiliates and/or customer and health regulatory agencies on the new product submissions and pre-launch variations. Ensure documents are of high-quality standard to meet one cycle review from Regulatory authorities. Review submission and / or approval notifications for new product applications submitted to Regulatory agencies. Monitors and reports on the progress/status of submissions, planned changes and product launches to the Reporting Manager. Support reporting manager in identifying high performers within team and prepare their development plan. Co-ordinate with third party manufacturers for document requirement and query response (as required) of in-licensed projects. Review of database and trackers to ensure accuracy of information. Regular interactions with stakeholders to discuss expectations, deliverables/priorities. Manage CCR related activities such as CCR assessment, document verification and closing of RA approval tracker. Works with other functional areas to resolve issues related to regulatory submissions, compliance and internal processes. Monitors and reports on the progress/status of projects to the Reporting Manager and other functional groups (as applicable). Actively works with reporting manager to suggest, develop and obtain own Key Performance Measures. Act as a back-up for other team members and as a designate to the Reporting Manager, as required. Liaises with functional groups to request and/or provide documents relevant to new product submissions, deficiencies, pre-launch variation. Contributes and encourage team members towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect. Works as a member of a team to achieve all outcomes. Completion of all the assigned training courses in timely manner. Utilizes open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Integrity, Courage, Teamwork, Innovation. Utilizes networks to attract and hire talent in a comprehensive, differentiated, and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process. Ensures adherence of team members (direct reports) with all compliance programs and company policie .