Senior Manager, US Advertising & Promo Compliance

Alexion; Boston (MA); On-site; USD 117,000 - 175,000; Full time

Job summary

AstraZeneca in the United States is seeking a regulatory advertising and promotions professional to oversee US promotional compliance for assigned products, ensuring materials are fair-balanced and FDA-compliant. You will collaborate with medical, legal, regulatory, commercial, and regulatory operations to translate guidance into actionable directions.

Key responsibilities include reviewing materials, serving as the primary OPDP contact, guiding label updates, and helping develop processes for

Qualifications

• Bachelor’s degree required.
• 3 years of relevant experience or PharmD post-doctoral fellowship.
• Strong knowledge of US advertising and promotional regulations.
• Experience communicating with OPDP.
• Ability to assess regulatory risk and advise management.
• Knowledge of industry compliance trends.

Responsibilities

• Review US promotional and non-promotional materials for FDA compliance.
• Serve as primary contact for OPDP/APLB for assigned products.
• Provide regulatory training on promotion requirements.
• Advise product development teams on advertising and promotion issues.
• Communicate labeling changes to stakeholders and ensure proper implementation.
• Develop processes for the creation, review and approval of promotional materials.
• Stay current with FDA enforcement actions and regulatory standards.

Skills

Regulatory compliance knowledge

OPDP negotiation experience

Risk assessment

Cross-functional collaboration

Influence and leadership

Prioritization and deadlines

Product launches experience

Analytical problem solving

Marketing concepts/tools (internet & 社

Education

Bachelor’s degree

Job description

AstraZeneca in the United States is seeking a regulatory advertising and promotions professional to oversee US promotional compliance for assigned products, ensuring materials are fair-balanced and FDA-compliant. You will collaborate with medical, legal, regulatory, commercial, and regulatory operations to translate guidance into actionable directions.

Key responsibilities include reviewing materials, serving as the primary OPDP contact, guiding label updates, and helping develop processes for