For the expansion of our regulatory team, argenx is looking for an Associate Director/Director Regulatory Affairs, argenx, based in Europe, to support the rapid growth needed for successful commercialization.
Key Accountabilities and Responsibilities:
The Associate Director/Director Regulatory Affairs is a key member of the global regulatory team. This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role will play a critical role across the product life cycle and will be a key advisor and enabler 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.
Your primary areas of focus are:
Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally
Help guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings
Oversee 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 including INDs, BLAs, and MAAs, and other areas as requested
Provide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing, payment of program user fees
Monitor, interpret, and communicate changes to the global regulatory landscape as required
Serve as the regulatory affairs business partner to local commercialization teams
Partner with medical, 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
Desired Skills and Experience:
Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDA
PhD or PharmD preferred
Prior experience working in rapidly growing pharmaceutical organizations is desirable
A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines, specifically in United States
Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA
Affinity with science and ability to interact with scientists and clinicians
Experience interacting with regulatory authorities, especially the FDA and EMA
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
Track record of successful interactions with regulatory and health authorities
You are a connector, building relationships and partnering across the organization to achieve the company goals
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 show strong leadership with proven ability to build, motivate and develop a team
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
