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Job Description
Takeda Pharmaceutical
Lexington, MA
This position is Hybrid
Reports to Director, Ad/Promo Regulatory Review
About the role:
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.
Manage at least one (1) individual Brand or one (1) component of a therapeutic area (e.g., consumer or professional promotion) for multiple brands; support other Ad/Promo Regulatory team members.
Independently provide 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.
How you will contribute:
Manage at least one (1) individual Brand or one (1) component of a therapeutic area (e.g., consumer or professional promotion) for multiple brands; support other Ad/Promo Regulatory team members.
Work 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.
Evaluate advertisement and promotional precedents for marketed products to help provide well-supported and clear guidance to important partners.
Evaluate materials to ensure compliance with FDA regulations, guidance, corporate standards and goals.
Assess the impact of proposed labeling changes for a product and its potential impact on advertising and promotional materials.
May be chair of promotional review meetings. Assist Commercial with the planning and prioritization of proposed promotional and disease state materials.
Understand and interpret scientific data as it relates to regulatory requirements and strategy for given claims for therapeutic area(s).
Understand broad concepts within regulatory affairs; identify regulatory issues; offer creative solutions and strategies, including risk mitigation strategies; demonstrate increasing independence beyond single therapeutic area.
Review standards within the electronic approval system (EAS) are upheld, and needs are assessed and addressed.
Support metrics to measure the effectiveness of the promotional review process and provides recommendations for process improvements to address potential issues.
Other responsibilities as assigned
Minimum Requirements/Qualifications
Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD).
3 years' experience in drug, biologic and device Regulatory Affairs or related field
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.
Maintain current knowledge of applicable government regulations, those related to advertising and promotion including major global codes and regulations. Have knowledge of historical enforcement actions and can use this when offering recommendations to partners.
Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
Deal with issues of important importance, provides regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
Model leaders at all levels daily.
Work well with others, especially on a team.
Excellent oral and written skills, timeline responsibilities
Problem solve and identify alternative solutions before escalation
Travel - 10% - 15% Meetings/Conferences
What Takeda can offer you:
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
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 and company match of charitable contributions
Family Planning Support
Flexible Work Paths
Tuition reimbursement
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
You will be classified as "hybrid" observing Takeda's Hybrid and Remote Work policy.
Observing the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
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EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
