Sr. Regulatory Affairs Associate

Janssen Inc., member of the Janssen Pharmaceutical Companies of Johnson & Johnson, is currently hiring for a Sr. Regulatory Affairs Associate located in Toronto, Ontario. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen, Inc. is part of the Janssen Pharmaceutical Companies. In this role, you will: Develop and implement regulatory strategic plans for product registration and lifecycle management. Manage the preparation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports to Health Canada, and maintain the life cycle of currently marketed products (the focus of this role is clinical/therapeutic not CMC). Manage the development and review of responses to Health Canada queries (e.g. clarifaxes, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner. Lead interactions with Health Canada throughout the submission review cycle (in partnership with Director, Regulatory Affairs) to ensure timely regulatory approval, and optimal labelling. Work with the Global Regulatory Affairs (GRA) 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. Address key emerging issues (e.g. new safety or quality findings) and the associated risk communications. Provide regulatory guidance 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 of required changes to systems/processes. Participate in the improvement of departmental processes and initiatives to enhance the internal work environment. Qualifications A Bachelor's of Science in biological or related sciences required. A Master's of Science or PhD preferred. A minimum of 4 years (or 2 years with MSc/PhD) of pharmaceutical or medical device Regulatory Affairs or related experience is required, which can include Regulatory Affairs certification. Knowledge of the drug development process is required. Knowledge of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions is required. Experience preparing therapeutic/labelling submissions is desirable. Strong scientific writing skills are required. Ability to interpret and summarize clinical data is required. Ability to interpret basic biostatistics and observational research methodologies highly desirable. Strong problem solving and analytical skills are required. This position is to be located in Toronto, Ontario and will require up to 10% travel. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of full COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location Canada-Ontario-Toronto-19 Green Belt Drive Organization Janssen Inc. (7710) Job Function Regulatory Affairs Requisition ID 2206069616W