Senior Manager, US Medical Ad/Promo Regulatory Review

Objectives

• Understand and interpret complex issues in relation to regulatory requirements and promotional strategy.
• Mentor and help develop staff.
• Assist with training and sharing technical and regulatory guidance to staff.
• Serve as the chair of promotional review meetings and assist Commercial with the planning and prioritization of proposed promotional and disease state materials.
• May present to senior management, and present regulatory topics to cross-functional teams.
• May serve as primary liaison with OPDP and APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
• Ensure review standards within the electronic approval system (EAS) are upheld, and business needs are assessed and addressed.
• Support metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues.

Position Accountabilities

• Collaborate with colleagues in Regulatory Affairs, Medical, Legal, Commercial, and Compliance organizations and applies Regulatory knowledge to ensure promotional and non-promotional material development is accomplished following internal processes and standards.
• Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
• Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
• Understand broad concepts within Regulatory Affairs and potential effects across the organization.
• Identify regulatory issues. Offer creative solutions and strategies, including risk mitigation strategies.
• Evaluate regulatory risks and make recommendations relative to the promotional strategy.
• May provide management of individuals including mentoring, performance management, and staffing decisions.
• Mentor and develop staff.
• Identify and propose solutions to management for any resource gaps for brand responsibilities.
• Present to senior management and cross-functional teams regarding shared insights from FDA advisory comments, recent enforcement actions, and guidance documents.
• Collaborate with the International Regulatory Ad/Promo review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns).
• Other responsibilities as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS

• Bachelor's Degree in life science or equivalent.
• Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• You have a minimum of 4 years' experience in drug, biologic or device Regulatory Affairs or related field, including a minimum of 2 years' experience specific to Regulatory Affairs – Advertising and Promotion.
• Candidates with experience in related fields may also be considered.
• Knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products.
• Experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) preferred.
• Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
• Deal with issues of importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
• Understand the phases, processes and techniques used within a clinical development environment, and can contribute to clinical study design discussions.
• Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion, including important global codes of practice and regulations.
• Have knowledge of historical enforcement actions and can use this when offering recommendations to stakeholders.
• Excellent oral and written skills, timeline responsibilities, negotiations skills.
• Work well with others, especially on a cross-functional team, direct reports and senior leadership.
• Prior leadership of individuals/team not required, but preferred.
• Ability to effectively manage and bring working teams together for common objectives.
• Model leaders at all levels daily.
• Licenses/Certifications: None required. Regulatory Affairs Certification (RAC) desirable.
• Travel Requirements: Travel to meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately up to 20% travel.