Director, Regulatory Affairs

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

The Director Regulatory Affairs is a key member of - the global regulatory and quality team. This role serves as a close business partner and facilitator of regulatory and quality activities, and is expected to contribute to developing sound regulatory strategies globally with a focus on Brazil. 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 Brazil. 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.  
 

Roles and Responsibilities:

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

• Provide regulatory support for Expanded Access Programs

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

• Oversee regulatory affairs vendors involved in Brazilian filings and help ensure high quality interactions with ANVISA

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

• Providing guidance and support to cross-functional teams and representing the company in interactions with authorities and industry associations

• Provide regulatory leadership with post-approval activities including application maintenance activities s

• Monitor, interpret, and communicate changes to the Brazilian 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 business strategy within the Brazilian team and the broader global regulatory and development teams

• Ability to assume civil and administrative responsibility as the company’s RT

• Oversee all activities related to:

• Drug storage, handling, dispensing, and distribution

• Quality assurance and control procedures

• Coordinate and supervise the implementation of the local Quality Management System

• Ensure all licenses, permits, and technical records are up to date

Education, Experience and Qualifications:

• Minimum 10+ years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5 years must have been in global leadership roles with a focus on ANVISA regulatory activities

• PharmD required

• Prior experience working in rapidly growing pharmaceutical organizations is preferred

• 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 Brazil/South America

• Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with the ANVISA

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

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

• In depth knowledge of applicable Brazilian legislation (ANVISA RDCs, Lei 5.991/1973, Portaria 344/1998, etc.)

• Must be registered with the CRF

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

• 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

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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