Takeda Pharmaceutical (US)
Associate Director, Global Regulatory Affairs, Advertising and Promotion
Takeda Pharmaceutical (US), Boston, Massachusetts, United States, 02298
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Job Description 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 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.
How you will contribute
Act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs.
Serve as the regulatory advisor within the core Medical, Legal, and Regulatory review functions of the Commercial Material Review Process (CMRP). Provide guidance during development, review, approval, and implementation of medical and commercial materials.
Be the product or project business lead for global CMRP at Takeda.
Chair CMRP meetings—communicate comments to the coordinator, diffuse disputes, maintain focus on stakeholders, and oversee escalation as needed.
Act as a strategic partner from clinical trial development through marketing and maintenance phases of the product lifecycle.
Serve as a subject matter expert on EFPIA, IFPMA, and FDA codes, guidance, industry standards, complaints/violations, and innovative promotional platforms.
Exercise decision‑making authority within the CMRP to ensure compliance, patient safety, and alignment with Takeda’s values.
Minimum Requirements / Qualifications
BSc degree preferred; BA accepted.
8+ years of pharmaceutical industry experience, including 6 years regulatory experience or 5+ years regulatory and/or related experience.
Deep understanding of ABPI, EFPIA and other international codes and guidance on advertising and promotion of prescription medicines.
Experience in prescription medicine promotion development and review process.
Strong interpersonal, strategic, and analytical thinking skills.
Excellent communication—written and verbal—to manage, motivate, and drive decisions within teams.
Proven negotiation, influencing without authority, and conflict‑resolution skills.
Experience with cross‑functional people management and fostering a positive team culture.
Ability to work independently, take initiative, and meet deadlines.
Previous experience in an advertising and promotion role.
Proven expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards.
Strong leadership, negotiation, and conflict resolution skills within cross‑functional teams.
Strategic mindset to assess and advise regulatory impacts across the product lifecycle.
Adept at guiding teams through complex advertising and promotion processes with patient safety and compliance focus.
Additional Skills
Leadership—motivate team members and guide others toward Takeda’s goals.
Strategic approach—identify, create, and implement processes for reviewing promotional and disease‑awareness materials.
Change management—advocate and implement change positively across the organization.
Analytical and problem‑solving—understand complex issues and propose achievable solutions.
Communication—express oneself clearly and concisely.
Interpersonal flexibility—adapt to personalities respectfully to achieve goals.
Teamwork—work well in a cross‑functional environment.
Presentation skills—deliver presentations with appropriate messaging and focused recommendations.
More about us At 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. Certified 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.
This position is currently classified as “remote” following Takeda’s Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary Location: Massachusetts – Virtual
U.S. Base Salary Range: $153,600.00 – $241,340.00
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.
U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue 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.
Locations Massachusetts – Virtual
Worker Type Employee
Worker Sub‑Type Regular
Time Type Full time
Job Exempt Yes
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Job Description 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 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.
How you will contribute
Act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs.
Serve as the regulatory advisor within the core Medical, Legal, and Regulatory review functions of the Commercial Material Review Process (CMRP). Provide guidance during development, review, approval, and implementation of medical and commercial materials.
Be the product or project business lead for global CMRP at Takeda.
Chair CMRP meetings—communicate comments to the coordinator, diffuse disputes, maintain focus on stakeholders, and oversee escalation as needed.
Act as a strategic partner from clinical trial development through marketing and maintenance phases of the product lifecycle.
Serve as a subject matter expert on EFPIA, IFPMA, and FDA codes, guidance, industry standards, complaints/violations, and innovative promotional platforms.
Exercise decision‑making authority within the CMRP to ensure compliance, patient safety, and alignment with Takeda’s values.
Minimum Requirements / Qualifications
BSc degree preferred; BA accepted.
8+ years of pharmaceutical industry experience, including 6 years regulatory experience or 5+ years regulatory and/or related experience.
Deep understanding of ABPI, EFPIA and other international codes and guidance on advertising and promotion of prescription medicines.
Experience in prescription medicine promotion development and review process.
Strong interpersonal, strategic, and analytical thinking skills.
Excellent communication—written and verbal—to manage, motivate, and drive decisions within teams.
Proven negotiation, influencing without authority, and conflict‑resolution skills.
Experience with cross‑functional people management and fostering a positive team culture.
Ability to work independently, take initiative, and meet deadlines.
Previous experience in an advertising and promotion role.
Proven expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards.
Strong leadership, negotiation, and conflict resolution skills within cross‑functional teams.
Strategic mindset to assess and advise regulatory impacts across the product lifecycle.
Adept at guiding teams through complex advertising and promotion processes with patient safety and compliance focus.
Additional Skills
Leadership—motivate team members and guide others toward Takeda’s goals.
Strategic approach—identify, create, and implement processes for reviewing promotional and disease‑awareness materials.
Change management—advocate and implement change positively across the organization.
Analytical and problem‑solving—understand complex issues and propose achievable solutions.
Communication—express oneself clearly and concisely.
Interpersonal flexibility—adapt to personalities respectfully to achieve goals.
Teamwork—work well in a cross‑functional environment.
Presentation skills—deliver presentations with appropriate messaging and focused recommendations.
More about us At 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. Certified 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.
This position is currently classified as “remote” following Takeda’s Hybrid and Remote Work policy.
Takeda Compensation and Benefits Summary Location: Massachusetts – Virtual
U.S. Base Salary Range: $153,600.00 – $241,340.00
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.
U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue 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.
Locations Massachusetts – Virtual
Worker Type Employee
Worker Sub‑Type Regular
Time Type Full time
Job Exempt Yes
#J-18808-Ljbffr