Manager, Regulatory Affairs, Canada

PURPOSE OF THE ROLE

For the expansion of our regulatory team, argenx is looking for a Manager of Regulatory Affairs, argenx Canada, to support the rapid growth needed for successful commercialization. The role will report into Director of Regulatory Affairs, Canada



The Manager of Regulatory Affairs is a key member of the local and global regulatory team. This role serves as a close business partner with cross-functional teams. This role will prepare and provide input for regulatory submissions related to marketed and development products to Health Canada. The role will play a critical role across the product life cycle and will contribute towards the strategy of successful product launches and commercialization. In close collaboration with other functions and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, distribution, and post-approval regulatory activities, among others



REPORTING LINE

Director of Regulatory Affairs, Canada



ROLES AND RESPONSIBILITIES

• Provide strategic, operational and tactical regulatory insight on pre-approval and post-approval activities with a focus on Canada


• Help guide on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings with Health Canada


• Assist with oversight of regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators


• Working with the rest of the argenx regulatory team, provide hands-on contributions to regulatory filings, and other areas as requested


• Provide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing


• Monitor, interpret, and communicate changes to the local regulatory landscape


• Serve as the regulatory affairs business partner to local commercialization teams


• Partner with medical, market access, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions


• Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams


• Supports the regulatory lead as regulatory representative within cross-functional teams to provide expert interpretation of relevant laws, regulations, and company policies


• Participate with global regulatory projects and initiatives as required


• Participate in local affiliate activities as a key member of Regulatory Affairs department


• Provide guidance to internal and external stakeholders on clinical trial and related applications


• Provide input into review of promotional and non-promotional materials as required

SKILLS AND COMPETENCIES

• Affinity with science and ability to interact with scientists and clinicians


• Ability to speak and interact with a diverse group of individuals on technical and business topics


• Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally


• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization


• A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills


• You excel in a fast-paced, results-driven, highly accountable environment


• You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done


• You resonate with the values of argenx and you are ready to drive the Company Culture


• You combine strategic thinking with the ability to execute, both individually and by leading teams (in a matrix environment) to achieve operational excellence in the face of challenging goal

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Minimum 2-4 years of experience in Regulatory Affairs within the pharmaceutical industry is required, experience with rare disease is preferred


• Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines, and policies for the lifecycle management for products, including experience in clinical and quality (CMC) submissions


• Must possess understanding of the Health Canada Drug Establishment Licence regulations


• Must possess a thorough understanding of drug development and commercialization process


• Demonstrated ability to develop regulatory strategies aligned with commercial objectives, with a focus on rare disease


• Excellent communication and negotiation skills


• Good influencing and relationship management skills


• Sound written and verbal communication skills


• Exceptional attention to detail and good organizational and priority management skills


• Ability to work within a cross-functional environment at global and local levels, including with commercial, medical affairs, market access, safety and quality teams