Talent.com
Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead
Associate Director, Global Regulatory Affairs-Advertising and Promotion Review LeadTakeda • Boston, MA, United States
Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead

Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead

Takeda • Boston, MA, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead

Join to apply for the Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead role at Takeda

About the Role

At Takeda, we are a forward‑looking, world‑class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D 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.

The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead will support our growing Oncology Portfolio. You will be accountable for management of all assigned programs / products as the internal expert on US codes, guidance, and industry standards pertaining to prescription medicine promotion.

How you will contribute

  • Serve as GRA A&P SME for assigned products and projects.
  • Regulatory advisor as the “R” in the core Medical, Legal, Regulatory review functions of the Commercial Material Review Process (CMRP) and Medical Material Review Process (MMRP) for both Commercial and Medical material development, review, approval, and implementation.
  • Product or project business lead for global CMRP at Takeda.
  • CMRP Meeting Chair—pause to communicate comments to coordinator, diffuse team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders, the patients.
  • Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle.
  • Subject matter expert on FDA code / regs, guidance, industry standards, complaints / violations, and innovative promotional platforms, with additional training on International Codes (e.g., EFPIA, IFPMA) and guidelines for global product support.
  • Partner closely with line‑management, Oncology GRA A&P Portfolio Lead and inform or bring in Head of GRA A&P for complex review concepts or topics.
  • Empowered decision‑maker within the CMRP.

Minimum Requirements / Qualifications

  • Bachelor’s Degree in a science‑related field is required.
  • Master’s Degree preferred. Minimum of 3 years’ experience required in material review and approval process of pharmaceutical / biologics promotion.
  • Ability to understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines.
  • Experience in prescription medicine promotion development and review process.
  • Strong interpersonal skills with ability to demonstrate strategic and analytic thinking.
  • Demonstrated ability to communicate clearly and concisely.
  • Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams.
  • Proven skills in negotiation, influencing without authority and working diplomatically through conflict.
  • Demonstrated cross‑functional people management with a desire to foster a positive team culture.
  • Ability to work independently, take initiative and complete tasks to deadlines.
  • Previous experience in an advertising and promotion role.
  • More about us

    At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programmes. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. We are a Global Top Employer, encouraging innovation and striving for excellence in everything we do. We foster an inclusive, collaborative workplace, united by an unwavering commitment to deliver better health and a brighter future to people around the world.

    This position is currently classified as “remote” following Takeda's Hybrid and Remote Work policy.

    Location & Compensation

    Location : Massachusetts – Virtual

    U.S. Base Salary Range : The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including qualifications, experience, skills, education, certifications, and location. U.S. based employees may be eligible for short‑term and / or long‑term incentives, medical, dental, vision insurance, 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well‑being benefits, up to 80 hours of sick time, and accrual of up to 120 hours of paid vacation.

    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.

    #J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Associate Regulatory • Boston, MA, United States

    Job_description.internal_linking.related_jobs
    Associate Director, Global Regulatory Affairs CMC Devices and Combination Products

    Associate Director, Global Regulatory Affairs CMC Devices and Combination Products

    AstraZeneca GmbH • Boston, MA, United States
    serp_jobs.job_card.full_time
    The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA‑CMC) Devices and Combination Products plays a pivotal role in implementation of global CMC regulatory...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Rhythm Pharmaceuticals • Boston, MA, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases.We develo...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Global Regulatory Strategy Director – Rare Diseases

    Global Regulatory Strategy Director – Rare Diseases

    AstraZeneca • Boston, MA, United States
    serp_jobs.job_card.full_time
    A global biopharmaceutical company is seeking a Senior Regulatory Affairs Director in Boston to oversee global regulatory strategies for innovative products. The role requires extensive regulatory e...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_hour • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Associate Director, Regulatory Compliance

    Associate Director, Regulatory Compliance

    Alnylam Pharmaceuticals • Cambridge, MA, United States
    serp_jobs.job_card.full_time
    The Associate Director, Regulatory Compliance will help develop and drive department-wide global regulatory compliance strategies, with input from key program, Regulatory, Quality and CMC stakehold...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Director, Regulatory Affairs – Contract

    Associate Director, Regulatory Affairs – Contract

    Nuvation Bio, Inc. • Boston, MA, United States
    serp_jobs.job_card.full_time
    Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Director / Director of Drug Safety / PV

    Associate Director / Director of Drug Safety / PV

    Vivid Resourcing • Boston, MA, US
    serp_jobs.job_card.full_time
    Senior Director Pharmacovigilance.Pharmacovigilance / Drug Safety.The Director of Pharmacovigilance will lead and oversee all aspects of post-marketing and clinical safety surveillance activities, ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director - Regulatory Strategy

    Associate Director - Regulatory Strategy

    Eli Lilly and Company • Boston, MA, United States
    serp_jobs.job_card.full_time
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director, Regulatory Affairs : Ad & Promotion (Remote)

    Director, Regulatory Affairs : Ad & Promotion (Remote)

    Vertex Pharmaceuticals • Boston, MA, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    A global biotechnology company is seeking a Director of Regulatory Affairs Advertising and Promotion to lead regulatory strategies for promotional communications. The ideal candidate will have exten...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director Regulatory Labeling

    Associate Director Regulatory Labeling

    Akebia Therapeutics • Cambridge, MA, United States
    serp_jobs.job_card.full_time
    Associate Director Regulatory Labeling .Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Regulatory Diagnostics Associate Director

    Regulatory Diagnostics Associate Director

    Novartis • Cambridge, Massachusetts, United States
    serp_jobs.job_card.full_time
    This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.The Regulatory ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director, Global Regulatory Strategy (Consulting)

    Senior Director, Global Regulatory Strategy (Consulting)

    Halloran Consulting Group, Inc. • Boston, MA, United States
    serp_jobs.job_card.full_time
    A leading consulting firm in health strategy seeks a Senior Director of Regulatory Strategy Consulting in Boston.In this role, you will utilize your substantial regulatory experience to shape globa...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead

    Associate Director, Global Regulatory Affairs-Advertising and Promotion Review Lead

    Takeda Pharmaceutical (US) • Boston, MA, US
    serp_jobs.job_card.full_time
    By 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 lin...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Associate Director Regulatory Strategy

    Associate Director Regulatory Strategy

    EPM Scientific • Boston, MA, US
    serp_jobs.job_card.full_time
    Associate Director of Regulatory Strategy.A rapidly growing pharmaceutical company is expanding its regulatory leadership team and seeking a strategic, execution-oriented.Associate Director of Regu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director, Global Regulatory Strategy - Hybrid+Equity

    Senior Director, Global Regulatory Strategy - Hybrid+Equity

    Alexion Pharmaceuticals, Inc. • Boston, MA, United States
    serp_jobs.job_card.full_time
    A leading biopharmaceutical company in Boston is looking for a Senior Director, Global Regulatory Strategy to spearhead the regulatory strategy for early-stage programs. This role requires a deep un...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Foundation Medicine • Boston, MA, United States
    serp_jobs.job_card.full_time
    The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Regulatory Diagnostics Associate Director

    Regulatory Diagnostics Associate Director

    Novartis Group Companies • Cambridge, MA, United States
    serp_jobs.job_card.full_time
    The Regulatory Diagnostics Associate Director (RDAD) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including Companion Diagnostics (...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Global Submission Management

    Associate Director, Global Submission Management

    Eisai • Boston, MA, United States
    serp_jobs.job_card.full_time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs

    Olema Oncology • Boston, MA, United States
    serp_jobs.job_card.full_time
    Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs at Olema Oncology.Reports to the Senior Vice President of Regulatory Affairs. Location : Boston, MA or San Francisco, CA.Domestic...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted