Averitas Pharma

Compliance

• Lead and manage the US Materials Review processes (LMR & PARC), ensuring robust procedures for the creation, review, and approval of promotional, non‑promotional, scientific exchange, and external communications that meet all regulatory requirements and support operational excellence
• Ensure compliant review and approval of all professional and direct‑to‑consumer promotional and non‑promotional materials for approved US products managed by Averitas
• Oversee review of materials for investigational products, ensuring all US-facing materials adhere to FDA regulations and avoid any implication of pre‑approval promotion
• Build strong partnerships and collaborate effectively with cross-functional Medical, Legal, and other LMR team members to enable timely, aligned decision‑making
• Serve as the Subject Matter Expert on FDA advertising and promotion regulations, providing strategic guidance on promotional concepts, launch strategies, branding, campaigns, and materials for both approved and investigational products
• Collaborate with Global Regulatory Affairs to ensure US promotional and sales training materials reflect current US prescribing information and align with global product strategy where appropriate
• Act as the primary liaison to FDA’s Office of Prescription Drug Promotion (OPDP), including oversight of FDA Form 2253 submissions for assigned products
• Advise US Commercial teams on regulatory requirements and risk‑based best practices to support compliant planning and execution of marketing strategies
• Partner with Global Regulatory Affairs on the development, review, and approval of US labeling (e.g., carton/container labeling and US prescribing information)
• Ensure consistent application of regulatory standards across US Materials Review teams and verify adherence to established processes, documentation practices, and governance expectations
• Represent US Commercial Regulatory in relevant cross-functional initiatives, including committees, training programs, and due diligence activities
• Lead additional regulatory activities as assigned beyond advertising and promotion, contributing to broader regulatory initiatives as needed
• Provides guidance and oversight to Regulatory Affairs team members and contractors as needed, fostering a collaborative, high‑performance working environment grounded in regulatory excellence, trust, and proactive partnership
• Partner cross-functionally to drive consistency, efficiency, quality, and compliance, providing clear, balanced regulatory risk assessments and facilitating productive risk‑benefit discussions

Associate Director / Director, Regulatory Affairs, Advertising & Promotion

Account Manager

• Create and execute strategic plans focused on achieving territory-specific goals/KPIs, utilizing organizational tools (CRM, data, DOMO, and other analytics) to identify relevant opportunities and ensure sales effectiveness.
• Engage with account C-Suite and executive teams, across multiple sites and locations, allowing for a clear understanding of how to develop the account into a site of care that provides seamless experience and continued access to QUTENZA for appropriate patients.
• Provide superior full-service account support regarding all aspects of product access and education, including training HCPs and staff on proper application guidelines of Qutenza® for optimal patient efficacy.
• Build and maintain strong, lasting relationships with key customers, staff, and national/regional KEEs as a trusted advisor.
• Build an influential network of supporters to expand QUTENZA’s awareness within these accounts. This would include working with multiple departments (Endo, Pain, Podiatry, Neurology, etc.) within certain advanced archetypes or developing Alternate Sites of Care (ASOC) to meet the needs of the account.
• Effectively prioritize and demonstrate commitment to maneuvering through obstacles and roadblocks, while remaining flexible, and resilient in a fast-paced, dynamic selling environment.
• Engage and inspire others with a positive, problem-solving approach when challenged by adversity.
• Pursue self-driven learning opportunities with demonstrated rigor to become a clinical pain market expert.
• Leverage and share knowledge with peers and cross-functional colleagues to ensure success across the organization.
• Create and hold oneself and teammates accountable to an atmosphere of transparency, trust, and a commitment to success.

Key Account Manager – Memphis

• Create and execute strategic plans focused on achieving territory-specific goals/KPIs, utilizing organizational tools (CRM, data, DOMO, and other analytics) to identify relevant opportunities and ensure sales effectiveness
• Engage with account C-Suite and executive teams, across multiple sites and locations, allowing for a clear understanding of how to develop the account into a site of care that provides seamless experience and continued access to QUTENZA for appropriate patients
• Provide superior full-service account support regarding all aspects of product access and education, including training HCPs and staff on proper application guidelines of Qutenza® for optimal patient efficacy
• Build and maintain strong, lasting relationships with key customers, staff, and national/regional KEEs as a trusted advisor
• Build an influential network of supporters to expand QUTENZA’s awareness within these accounts
• Effectively prioritize and demonstrate commitment to maneuvering through obstacles and roadblocks, while remaining flexible, and resilient in a fast-paced, dynamic selling environment
• Engage and inspire others with a positive, problem-solving approach when challenged by adversity
• Pursue self-driven learning opportunities with demonstrated rigor to become a clinical pain market expert
• Leverage and share knowledge with peers and cross-functional colleagues to ensure success across the organization
• Create and hold oneself and teammates accountable to an atmosphere of transparency, trust, and a commitment to success

Associate Director / Director, Regulatory Affairs, Advertising & Promotion

Key Account Manager – Memphis

Key Account Manager – KAM