Job Description

ppBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. /p h3bJob Description /b /h3 h3bAbout the role: /b /h3 pAt Takeda, we are a forward-looking, world‑class RD organization that unlocks innovation and delivers transformative therapies to patients. By focusing RD efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. /p pThe Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA AP) Review Lead is accountable for management of all assigned programs/products as the internal expert on US and international Codes, guidance, and industry standards pertaining to prescription medicine promotion. /p h3bHow you will contribute: /b /h3 ul lipAs our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs. /p /li lipYou will be the Regulatory Advisor and function as the “R” in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP). Provide regulatory guidance during development, review, approval, and implementation of medical and commercial materials. /p /li lipYou will be product or project business lead for global CMRP at Takeda /p /li lipCMRP Meeting Chair - pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment. /p /li lipStrategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle /p /li lipSubject matter expert on EFPIA, IFPMA, and FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms /p /li lipAct as a strategic partner spanning clinical trial development through the marketing and maintenance phases of the product lifecycle. /p /li lipRegulatory Subject Matter Expert: Provide expertise on EFPIA, IFPMA, and FDA codes, regulations, guidance, industry standards, and innovative promotional platforms. /p /li lipExercise decision‑making authority within the CMRP to ensure compliance, patient safety, and alignment with Takeda’s values. /p /li /ul h3bMinimum Requirements/Qualifications: /b /h3 ul lipBSc Degree, preferred. BA accepted. /p /li lip8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience. /p /li lipYou can understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines. /p /li lipExperience in prescription medicine promotion development and review process. /p /li lipStrong interpersonal skills with ability to demonstrate strategic and analytic thinking. /p /li lipDemonstrated ability to communicate clearly and concisely. /p /li lipHighly effective written and verbal communication skills to manage, motivate and drive decisions within teams. /p /li lipProven skills in negotiation, influencing without authority and working diplomatically through conflict. /p /li lipDemonstrated cross‑functional people management with a desire to foster a positive team culture. /p /li lipAbility to work independently, take initiative and complete tasks to deadlines. /p /li lipPrevious experience in an advertising and promotion role. /p /li lipProven experience and expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards. /p /li lipStrong leadership, negotiation, and conflict resolution skills within cross‑functional teams. /p /li lipStrategic mindset and ability to assess and advise regulatory impacts across the product lifecycle. /p /li lipAdept in guiding teams through complex advertising and promotion processes with a focus on patient safety and compliance. /p /li /ul pAdditional Skills: /p ul lipLeadership Skills can lead and motivate team members. Develops, uses and shares knowledge and uses strong interpersonal skills to guide others (both inside and outside the department) toward the accomplishment of Takeda's goals and objectives. /p /li lipStrategic Approach – ability to identify, create and implement processes for the review of Promotional and Disease awareness materials. /p /li lipChange Management — ability to identify, advocate and implement change positively for the organizations Demonstrates flexibility and the ability to accommodate change. /p /li lipAnalytical and Problem‑Solving Skills - Excellent ability to understand complex issues and propose achievable solutions. /p /li lipCommunication Skills ability to express oneself clearly and concisely. /p /li lipInterpersonal Flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement. /p /li lipTeamwork - the ability to work well in a highly cross‑functional team environment. /p /li lipPresentation skills — create and deliver presentations with appropriate messaging and focused recommendations. /p /li /ul h3bMore about us: /b /h3 pAt Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. /p pCertified 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. /p pThis position is currently classified as "remote" following Takeda's Hybrid and Remote Work policy. /p /p #J-18808-Ljbffr