The Manager, US Medical Ad/Promo Regulatory serves as an internal resource on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
- Manages at least one (1) individual Brand or one (1) component of a therapeutic area (e.g., consumer or professional promotion) for multiple brands; supports other Ad/Promo Regulatory team members.
- Independently provides regulatory guidance and expertise to promotional review team on the assigned products(s) of responsibility and identifies regulatory requirements and data needed to ensure claims are supported for products.
- During the developmental stage, may be asked to provide promotional regulatory guidance for creation of the product labeling to enhance marketing of Takeda products.
- May support the preparation for FDA meetings.� Assist and may, where appropriate, attend FDA meetings.
- Works collaboratively 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, with some oversight from manager.
- Researches and evaluates advertisement and promotional precedents for marketed products to assist with providing well-supported and clear guidance to key stakeholders.
- Evaluates materials to ensure compliance with FDA regulations, guidance, corporate standards and policies and business objectives.
- Assesses the impact of proposed labeling changes for a particular product and its potential impact on advertising and promotional materials.
- May act as chair of promotional review meetings. Assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for given claims for therapeutic area(s).
- Understands broad concepts within regulatory affairs; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies; demonstrates increasing independence beyond single therapeutic area.
- 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.
- Other duties as assigned.
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 3 years' experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 1 year experience specific to Regulatory Affairs - Advertising and Promotion. Candidates with experience in related fields may also be considered.
- Knowledge of FDA regulations.�
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Maintains current knowledge of applicable government regulations, particularly those related to advertising and promotion including major global codes and regulations. Has knowledge of historical enforcement actions and is readily able to use this when offering recommendations to stakeholders.
- Ability to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
- Ability to deal with issues of critical importance, provides regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
- Demonstrates problem-solving ability and generates alternative solutions prior to elevation of issues to manager.
- Excellent oral and written skills, timeline responsibilities, negotiations skills. Works well with others, especially on a cross-functional team.
- Models leaders at all levels daily.
Willingness to travel to various meetings, including overnight trips.
Requires approximately up to 15% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs