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.
In partnership with the Regulatory Leads, the RPM drives submission projects forward through the translation of regulatory strategy to executable plans and coordination of cross-functional team efforts. The RPM utilizes in-depth knowledge of regulatory submission requirements, eCTD structure and associated planning software to create and maintain a detailed integrated Submission Plan that captures the list of dossier content, key activities, and timelines.
The RPM partners with the Indication Development Team (IDT), Regulatory Lead, the Project Manager (PM) and the asset Project Lead (PL) to ensure alignment with the regulatory prerequisites and overall product development plan. The RPM leads in the facilitation of submission team execution of operational plan, implementing Project Management techniques, processes and tools, as needed.
The RPM reports to the RPM Lead with a dotted line accountability to the Head of Regulatory Affairs.
Roles and Responsibilities:
The RPM partners with PM and Regulatory Leads as applicable and consults other Submission Team members to create an integrated and dynamic operational regulatory submission plan in support of projected global regulatory approval for assigned asset(s) in targeted regions, and therapeutic indications and/or presentations per corporate strategy;
Scenario planning taking into account all submission activities that rely on resources needed for assigned submission plans;
Creates visuals, reports to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders; anticipates delays and mitigates impact to timelines;
Ensures submission team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and meets target submission dates;
Enables function leads to ensure that all documents are prepared with global Regulatory/ Health Authority quality standards;
Leads submission planning discussions incl., setting agendas, minutes and follow up on key actions with stakeholders;
Works with functional teams to identify ways to optimize and accelerate submission timelines;
Partners with PMs to ensure submission project plan and cross-functional project plans are aligned and optimized;
Manages submission planning meetings, including agenda preparation, minute-taking, communication of decisions; tracking and resolution of action items;
Translates post-submission requirement into an executable post-submission plan;
Identifies any issues, risks, or impact due to changes in strategy and/or timelines throughout the submission process;
Identifies key learnings & best practices and shares lessons learned across programs in order to refine and improve submission processes;
Contributes to the development of the Project Community Centre to share best practices and tools across argenx Project Management community;
Leads and/or participates in cross-functional and functional workstreams/initiatives.
Skills and Competencies:
Strong leadership skills;
Strong communication and collaboration skills;
Strong interpersonal skills;
Strong project management skills (PMP certification is an advantage);
Ability to respond positively to continuous change and to bring creative solutions to challenges.
Education, Experience and Qualifications:
Requires a Master’s degree (or foreign equivalent) in Regulatory Affairs, Pharmaceutical Studies or a directly related biotechnology field with at least 2 years of Regulatory Project Management experience, including experience managing global submissions;
Experience must include three (3) years of experience in the following (experience may be gained concurrently):
Drug development experience within the distinct phases of development, in different disease areas;
One (1) year of experience in the following (experience may be gained concurrently):
Program Management experience within a regulated Pharmaceutical or Biotech environment;
Creating and maintaining Global submission plans to be compliant with regulatory timelines and capturing eCTD content and associated activities;
Pharma R&D;
Drug development project management using MSP; experience with One-pager Pro, Planisware and PowerBI is a plus;
Experience in development of biologicals and rare diseases.
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For applicants in the United States: The annual base salary hiring range for this position is $128,000.00 - $192,000.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.
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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