The Associate Director, US Medical Ad/Promo Regulatory serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
Capable of providing regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products and/or compounds.
Understands and interprets complex issues in relation to regulatory requirements and promotional strategy.
Able to mentor and develop staff. Supervises, trains and provides technical and regulatory guidance to staff.
Serves as the chair of promotional review meetings, and assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
Serves 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.
Ensures consistent review standards within the electronic approval system (EAS) are upheld, and business needs are assessed and addressed.
Supports metrics to measure and track the effectiveness and efficiency of the promotional review process and provides recommendations for process improvements to address potential issues.
Collaborates with Regulatory Affairs, Medical, Legal, Commercial, and Compliance, executes and approves key Commercial campaigns. Provides expert guidance to help evaluate and mitigate potential risk.
Serves 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.
Understands broad concepts within Regulatory Affairs and potential implications across the organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
Provides 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.
Presents to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
Serves 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.
Leads internal Ad/Promo project work streams (e.g., best practice documents) and active participant at team staff meetings (e.g., present FDA guidance/enforcement letters).
Collaborates 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.
SCOPE OF SUPERVISION:
SUPERVISED NUMBER OF EMPLOYEES
Managers/Supervisors 0-2 0
Exempt/Professional/Technical 0 0
Non-Exempt 0 0
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
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 leaders at all levels daily.
None required. Regulatory Affairs Certification (RAC) desirable.
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Requires approximately up to 25% travel.
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Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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