New · posted Oct 15
Takeda · Pharmaceuticals
Associate Director, US Medical Ad/Promo Regulatory Review
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
Join Takeda as an Associate Director, 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 report to the Director, US Medical Ad/Promo Regulatory. This is a remote role.
How you will contribute
• Understand and interpret complex issues in relation to regulatory requirements and promotional strategy.
• Mentor and help develop staff. Supervises, trains and provides 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.
• Serve 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.
• Present to senior management, and present regulatory topics to cross-functional teams.
• Ensure consistent 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.
What you need
Minimum Qualifications/Requirements
• 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. opment of marketing materials.
• 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.
Position Accountabilities
• Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance, executes and approves key Commercial campaigns. Provides expert guidance to help evaluate and mitigate potential risk.
• Serve 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.
• Understand broad concepts within Regulatory Affairs and potential implications across the organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
• Provide 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.
• Present to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents.
unit/therapeutic areas.
• Lead internal Ad/Promo project workstreams (e.g., best practice documents) and active participant at team staff meetings (e.g., present FDA guidances/enforcement letters).
• 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 duties as assigned.
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 25% travel.
Pay
$154,400 – $242,550 a year
Employer providedTakeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
U.S. Base Salary Range
$154,400.00 - $242,550.00
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.
For information about our benefits, please click here.
Working conditions
Location
• Remote within the US
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Massachusetts - Virtual
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
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 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.
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 3% below the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in Massachusetts8 roles publishing pay
Director roles in the US35 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $154,400 | — | $242,550 |
| Massachusetts (middle half) | $195,125 | $199,250 | $208,375 |
| All US (middle half) | $197,500 | $205,500 | $216,750 |
This role: Takeda's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 74 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 33 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership16
- GMP and compliance6
- Documentation and SOPs4
- Regulatory submissions2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Takeda on Regulatory Jobs
- 36
- Open roles
- 34
- Distinct roles
- 14
- Locations
By discipline
- Regulatory18 50%
- Quality12 33%
- Compliance & Safety5 14%
By level
- Director21 58%
- Senior & Principal9 25%
- Manager4 11%
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Associate Director, US Medical Ad/Promo Regulatory Review at Takeda
Open until filled. $154K–$243K a year, employer provided.