Associate Director, US Medical Ad/Promo Regulatory Review (REMOTE)

How you will contribute

• Understand and interpret complex issues in relation to regulatory requirements and promotional strategy.
• Mentor and help develop staff. Supervises, trains and provides 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.
• Serve as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
• Present to senior management, and present regulatory topics to cross-functional teams.
• Ensure consistent 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 Regulatory Affairs, Medical, Legal, Commercial, and Compliance, executes and approves key Commercial campaigns. Provides expert guidance to help evaluate and mitigate potential risk.
• Serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The role is responsible for thoroughly reviewing and assessing proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
• Understand broad concepts within Regulatory Affairs and potential implications across the organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
• Provide product development and label development strategies, as needed, to ensure promotional claims can be supported.
• May provide direct supervision of individuals including mentoring, performance management, and staffing decisions. Identifies and proposes solutions to management for any resource gaps for brand responsibilities.
• Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
• Serve as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding the use of claims for assigned business unit/therapeutic areas.
• Lead internal Ad/Promo project workstreams (e.g., best practice documents) and active participant at team staff meetings (e.g., present FDA guidances/enforcement letters).
• 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 duties as assigned.

Minimum Qualifications/Requirements

• Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• Ideal candidate has a minimum of 5 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years’ experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered.
• Extensive knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences.
• Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints.
• Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams.
• Provide leadership related to issues of critical importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights.
• Understands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed.
• Maintains current knowledge of applicable government regulations, particularly those related to advertising and promotion, including key global codes of practice and regulations. Has thorough knowledge of historical enforcement actions and is readily able to use this when offering recommendations to stakeholders.
• Excellent oral and written skills, timeline responsibilities, negotiations skills. Works well with others, especially on a cross-functional team, direct reports and senior leadership.
• Prior leadership of individuals/team preferred.
• Demonstrated leadership skills. Ability to effectively manage and bring working teams together for common objectives.
• Models leadership 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 25% travel.