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Associate Director, US Regulatory Ad/Promo Review, US Medical
Associate Director, US Regulatory AD/Promo Review, US Medical
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, US Regulatory AD/Promo Review in our Lexington, MA or Exton, PA office.
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.
Here, you will be a vital contributor to our inspiring, bold mission.
As an Associate Director, US Regulatory AD/Promo Review, you will be empowered to build strong partnerships and educate patients. In this role, you will contribute to Takeda’s mission by providing creditable scientific expertise.
- The Associate Director, US Medical Ad/Promo Regulatory Review 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 workstreams (e.g., best practice documents) and active participant at team staff meetings (e.g., present FDA guidances/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.
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 leadership 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.
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
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
EEO Verbiage for US Reqs
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.