Senior Manager, Regulatory Affairs Advertising and Promotion

argenx; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An innovative biotech company is seeking a Senior Manager in Regulatory Affairs to lead strategic guidance on promotional communications. This role involves ensuring compliance with FDA regulations while fostering collaboration across teams. The ideal candidate will possess strong communication skills, a deep understanding of regulatory standards, and the ability to think strategically in a dynamic environment. Join a forward-thinking organization that values innovation and patient-centric solutions, making a real impact in the field of immunology and autoimmune diseases.

Qualifications

• 5+ years of regulatory experience in the pharmaceutical or biotech industry.
• Bachelor’s degree in scientific or regulatory field; advanced degree preferred.

Responsibilities

• Regulatory reviewer for product-related communications and training materials.
• Prepare and submit promotional pieces to FDA.

Skills

Interpersonal Communication

Strategic Thinking

Regulatory Knowledge

Flexibility

Results-Driven

Education

Bachelor’s degree in scientific or regulatory field

Advanced degree (e.g., PharmD, JD)

Tools

Veeva Vault (PromoMats and MedComms)

Microsoft Office

Job description

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 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:

• Strong interpersonal, oral and written communication skills.
• High degree of professional ethics, integrity and responsibility with a focus on patient centricity.
• Shows flexibility and is open to change in a growing, multi-cultural environment.
• Capable of strategic thinking and proposing innovative solutions to complex initiatives.
• Comfortable in a results-driven, highly accountable environment where you can make a clear impact.
• In-depth knowledge of FDA regulations, OPDP standards, and industry best practices.
• Proficient in Veeva Vault (PromoMats and MedComms) and Microsoft Office.

Education, Qualifications and Experience:

• Bachelor’s degree in scientific or regulatory field; advanced degree preferred (e.g., PharmD, JD or equivalent).
• 5+ years of regulatory experience in the pharmaceutical or biotech industry, with a focus on advertising and promotion.
• Ability to work in Eastern Time Zone required.