What are the responsibilities and job description for the Senior Manager, Regulatory Affairs Advertising and Promotion position at Argenx?
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.
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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 Senior Manager, Regulatory Affairs Advertising & Promotion will provide strategic, operational and tactical regulatory guidance on promotional communications for commercial products, scientific exchange and disease state awareness materials, ensuring they comply with US laws and regulations, Guidance Documents and company policies, while supporting achievement of business objectives. This individual should also thrive in collaborative environments that foster co-creation with a focus on innovation.
Roles and Responsibilities :
- Serves as a regulatory reviewer on cross-functional argenx Medical, Legal and Regulatory review body for product-related communications, scientific exchange information, disease awareness and training materials
- Prepares and submits in close coordination with Regulatory Operations promotional pieces on form 2253 FDA submissions to OPDP
- Reviews, approves and documents materials to ensure they are consistent with labeling, truthful and non-misleading, fair-balanced with consideration to benefit / risk presentation in compliance with FDA regulations, OPDP guidance documents, and enforcement actions as well as company policies.
- Ensures that US Prescribing Information (USPI) is accurately and contextually incorporated into relevant external communications and changes to USPI are applied in a timely manner
- Maintains collaborative, efficient, and effective working relationships with cross-functional argenx teams (commercial, operations, medical, legal and regulatory)
- Monitors and informs organization on US regulatory promotional environment (e.g., the issuance of new FDA regulations / guidance, relevant FDA enforcement action and general awareness of industry practices, including those of competitors)
Skills and Competencies :
Education, Qualifications and Experience :
LI-Remote
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.
If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com. Only inquiries related to an accommodation request will receive a response.
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