Manage regulatory guidance for advertising and promotion, ensuring compliance with regulations while mentoring junior staff and supporting strategic initiatives.
Use Your Power for Purpose
At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health.
Role Summary
The Manager, US Regulatory Advertising and Promotion (US RAP) provides regulatory guidance and strategic support for the review of promotional communications, ensuring regulatory requirements and business needs are met in a manner compliant with regulatory standards and Pfizer internal policies. The Manager may interact with the Office of Prescription Drug Promotion (OPDP) or the Advertising and Promotional Labeling Branch (APLB) on routine matters, under the direction of more senior personnel. The Manager may mentor or provide guidance to more junior personnel within the group.
Role Responsibilities
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
RAP experience
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs
At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health.
Role Summary
The Manager, US Regulatory Advertising and Promotion (US RAP) provides regulatory guidance and strategic support for the review of promotional communications, ensuring regulatory requirements and business needs are met in a manner compliant with regulatory standards and Pfizer internal policies. The Manager may interact with the Office of Prescription Drug Promotion (OPDP) or the Advertising and Promotional Labeling Branch (APLB) on routine matters, under the direction of more senior personnel. The Manager may mentor or provide guidance to more junior personnel within the group.
Role Responsibilities
- Operate in collaboration with the lead US RAP Reviewer(s) to develop the skills necessary to become a fully independent reviewer and subject matter expert.
- With management oversight, review and advise on promotional communications ensuring they are:
- accurate, truthful and not misleading,
- presented in a fair and balanced manner
- consistent with applicable product labeling
- well-substantiated by current and scientifically valid evidence
- adherent to applicable advertising and promotion standards
- comply with all internal and external policies and procedures
- With management oversight, review and advise on non-promotional corporate/medical/scientific communications for compliance with regulations, guidance documents, and internal policies/best practices
- Identify potential regulatory risks and propose strategies to address/mitigate
- Represent US RAP perspective in cross-functional review team meetings
- Interact with OPDP/APLB staff on administrative and logistical issues for assigned products
- Contribute to development of functional area and cross-functional written procedures
- Monitor and update internal stakeholders on regulations, guidance, regulatory actions, and the competitive landscape
- Support execution of regulatory strategy
- Mentor or provide guidance to more junior individuals, as needed
BASIC QUALIFICATIONS
- BA/BS
- 4+ years relevant experience (allowances for experience may be made for advanced degrees)
- Proficiency in English
PREFERRED QUALIFICATIONS
- Life sciences degree
- Advanced degree in a relevant field (science, pharmacy, law)
RAP experience
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs
Top Skills
Advertising And Promotion
Compliance
Promotional Communications
Regulatory Standards
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