Associate Director, US Advertising & Promotion Regulatory Review
About the Role: Join Takeda as an Associate Director, US Advertising & Promotion Regulatory Review within the US Medical team. You will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. Your contributions will ensure regulatory compliance of promotional materials for assigned US products and/or compounds.
Key Responsibilities:
Serve as an internal expert on FDA regulations, guidance, and enforcement trends related to the promotion of prescription drug and biologic products.
Provide regulatory strategic oversight for complex products or multiple products within a therapeutic area.
Interpret complex regulatory issues and promotional strategies.
Mentor and develop staff by supervising, training, and providing technical and regulatory guidance.
Chair promotional review meetings and assist Commercial with planning and prioritizing promotional and disease state materials.
Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance teams to execute and approve key commercial campaigns while evaluating and mitigating potential risks.
Review and assess proposed promotional items to ensure completeness, accuracy, and regulatory compliance.
Offer creative solutions and risk mitigation strategies regarding regulatory issues.
Contribute to product development and labeling strategies to ensure promotional claims are supportable.
Manage individuals, including mentoring, performance management, and staffing decisions, identifying resource gaps when necessary.
Present insights from FDA advisory comments, enforcement actions, and guidance documents to senior management and cross-functional teams.
Act as the primary liaison with OPDP and/or APLB reviewers for advisory comments and interactions regarding promotional claims.
Minimum Requirements/Qualifications:
Bachelor’s Degree in Life Sciences or equivalent required; advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
Minimum 5 years' experience in drug, biologic, and/or device Regulatory Affairs or related fields, including 3 years specific to Regulatory Affairs – Advertising and Promotion.
In-depth knowledge of applicable regulations and regulatory guidance related to pharmaceutical/biologic advertising and promotion.
Experience managing major regulatory filings (e.g., launch advisory comment submission, responses to enforcement letters) or competitor complaints.
Ability to merge scientific principles with FDA law and regulations for marketing material development.
Leadership skills related to important regulatory issues where clear guidance may not exist.
Regulatory Affairs Certification (RAC) desirable.
Travel Requirements:
Willingness to travel up to 20%, including overnight and occasional international trips.
About Takeda: Takeda is transforming patient care with novel specialty pharmaceuticals and best-in-class patient support programs. Recognized as a Global Top Employer, Takeda fosters an inclusive, collaborative workplace driven by a commitment to deliver Better Health and a Brighter Future worldwide.
Work Model: Remote (in accordance with Takeda’s Hybrid and Remote Work policy)
Compensation:
Base Salary Range: $153,600.00 - $241,340.00 (depending on factors such as qualifications, experience, location, and skills).
Eligibility for short-term and long-term incentives.
Comprehensive benefits package including medical, dental, vision insurance, 401(k) with match, disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being programs, sick time (up to 80 hours annually), and vacation time (up to 120 hours annually for new hires).
Equal Employment Opportunity: Takeda is committed to fostering diversity and equal employment opportunities for all, regardless of race, color, religion, gender, sexual orientation, gender identity, parental status, national origin, age, disability, citizenship status, veteran status, or any other protected characteristic under applicable laws.
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Birmingham |Alaska :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Atlanta | Augusta | Rome |Hawaii :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
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Ingelheim am Rhein | Mainz |Rotherbaum :
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Saarbrucken |Saxony Anhalt :
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Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria |Denmark :
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France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
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Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Leiden |North Yorkshire :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Uxbridge | Mississauga | Richmond Hill | Australia | North York | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
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Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Netanya | Be'Er Sheva | Tel Aviv | Kfar Saba | Yavne |Italy :
Italy |Lombardy :
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Almaty |Remote Korea :
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Auckland |Lima Region :
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Manila |Mazovia :
Warsaw |Remote :
Remote - South America (Latin Americal) | Remote - Africa | Remote | Lenexa | Victoria | Remote - Europe | McFarland | Remote, USA | Remote - Middle East | Switzerland | Melbourne |Bucharest :
Bucharest |Makkah :
Riyadh | Rabigh | King Abdullah Economic City | Jeddah | Khulais | Najran |Nišava District :
Niš |Singapore :
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Peru | Argentina |Catalonia :
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Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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