Senior Manager, US Medical Ad/Promo Regulatory Review

Title: Senior Manager, US Medical Ad/Promo Regulatory Review

About the role:

Join Takeda as a Senior 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. You will support review of Patient Services and Corporate materials across different business units, including additional product responsibilities. As part of the US Medical team, you will report to the Director, Ad/Promo Regulatory Review. You will be based in either our Lexington, MA or Exton, PA home office. There may be an opportunity to consider remote candidates as well.

How you will contribute:

• Understand and interpret complex issues in relation to regulatory requirements and promotional strategy.
• Mentor and help develop staff. Assist with training and sharing 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.
• May present to senior management, and present regulatory topics to cross-functional teams.
• May serve as primary liaison with OPDP and APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
• Ensure 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 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.
• Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
• Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify regulatory issues. Offer creative solutions and strategies, including risk mitigation strategies.
• Evaluate regulatory risks and make recommendations relative to the promotional strategy.
• May provide management of individuals including mentoring, performance management, and staffing decisions. Mentor and develop staff. Identify and propose solutions to management for any resource gaps for brand responsibilities.
• Present to senior management and cross-functional teams regarding shared insights from FDA advisory comments, recent enforcement actions, and guidance documents.
• 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 responsibilities as assigned.

What you bring to Takeda:

• Bachelor's Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• You have a minimum of 4 years' experience in drug, biologic or device Regulatory Affairs or related field, including a minimum of 2 years' experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered.
• Knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products.
• Experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) preferred.
• Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
• 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.
• Understand the phases, processes and techniques used within a clinical development environment, and can contribute to clinical study design discussions.
• 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, direct reports and senior leadership.
• Prior leadership of individuals/team not required, but preferred.
• Ability to effectively manage and bring working teams together for common objectives.
• 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.

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 the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work.

Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

Empowering Our People to Shine

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.