Manager, US Medical Ad/Promo Regulatory Review

USA - 3310 Takeda Pharmaceuticals U.S.A., Inc.; Massachusetts; Híbrido; USD 164 000 - 200 000; Tempo integral

Resumo da oferta

Takeda is seeking a Manager of US Medical Ad/Promo Regulatory Review to serve as an internal expert on FDA regulations governing promotional material for prescription drugs and biologics. The role includes regulatory oversight of at least one product area and collaboration with Regulatory Affairs, Medical, Legal, Commercial and Compliance teams.

The position requires at least 3 years in drug/biologic regulatory affairs, including advertising and promotion, and flexible handling of complex

Qualificações

• Bachelor's degree in life science or equivalent; advanced degree preferred.
• Minimum 3 years in drug/biologic/device regulatory affairs or related field; 1 year in advertising & promotion regulatory affairs.

Responsabilidades

• Collaborate across Regulatory Affairs, Medical, Legal, Commercial and Compliance to ensure compliant promotion materials.
• Evaluate promotional materials against FDA regulations and internal standards.
• Assess labeling changes and impact on advertising and promotion.
• Provide regulatory guidance for product labeling during development to enhance marketing.
• Lead or chair promotional review meetings and support process improvements.

Conhecimentos

FDA regulations

Regulatory strategy

Cross-functional teamwork

Communication skills

Formação académica

Bachelor's degree in life science or equivalent

Advanced degree (PharmD, PhD, MS, MBA, JD) preferred

Ferramentas

Electronic Approval System (EAS)

Regulatory databases

Descrição da oferta de emprego

Job Description About the role

Join Takeda as a Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will also provide regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products and compounds.

Objectives

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.

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, 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

Bachelor's Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred. You have a minimum of 3 years' experience in drug, biologic 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 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 importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance. Understanding of scientific principles and regulatory/quality systems relevant to drug development. 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. Demonstrates problem‑solving ability and generates alternative solutions prior to elevation of issues to manager. 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.

Location

Remote within the US Takeda

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $116,000.00 - $182,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular Time Type

Full Time

Yes

Job Exempt

Yes

About Takeda

Takeda is an industry‑leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.