Regulatory Reviewer, Ad Promo

Eastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. Eastridge is seeking a Regulatory Reviewer, Ad Promo for a leading international pharmaceutical company. Fully Remote

Summary

The Regulatory Review and Ad Promo professional is responsible to serves as Regulatory reviewer for medical materials and commercial advertising and promotional materials for product, disease state, and training/education programs. This role involves close collaboration with cross-functional teams to review and approve promotional content for ensuring that all advertising and promotional materials for pharmaceutical products comply with, ensuring it adheres to FDA guidelines and other relevant regulations. This role would be responsible for timely submission of promotional materials to the FDA (e.g., FDA Form 2253 submissions)

Responsibilities:

• Responsible for timely and accurate review, and timely submission of promotional materials (i.e. FDA 2253 submissions) 

• Assumes a Regulatory role in the Promotional Review Committee (PRC) Process for assigned products to ensure compliance with FDA advertising and promotional regulations and guidelines for select product, disease state, and all medical education materials 

• Independently represents Regulatory Affairs on the Medical and Scientific Review Committee (MSRC) and be responsible for conducting the regulatory review of materials for assigned products/programs intended for use by the field medical team 

• Develop and maintain a business partnership environment with PRC and MSRC partner functions in the review and approval of advertising and promotional materials 

• Track and evaluate FDA guidance, policies and the overall regulatory environment and must be able to assess and communicate potential risk and impact to Sr. Leadership 

• Actively manages communications to Regulatory management, and ensures promotional claims are in compliance with terms of approved product registrations, current labelling, applicable laws, internal policies and external regulations 

• Proactively assesses advertising and promotion-related processes and procedures to enhance efficiencies and compliance 

• Maintain standard operating procedures and department working practices

Requirements:

• Bachelor’s degree (minimum) in a scientific or healthcare discipline 

• 6-10 years of experience in Regulatory Affairs with knowledge of regulatory processes, including submission to FDA of US Ad/Promo documents

• Proven track record and experience in Advertising & Promotional review committees with a thorough understanding of FDA guidance and regulations

• Extensive knowledge of electronic document management systems (e.g. Veeva Vault RIM) • Experience working and scientific knowledge in Oncology and Oncology therapeutic products 

• Highly organized with attention to detail and accuracy 

• Strong time management skills with the ability to multi-task and prioritize 

• Works effectively on cross-functional matrix teams 

• Possesses well-grounded knowledge of regulatory affairs principles, practices, and systems in the areas of marketed products and lifecycle management. 

• Knowledgeable in pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentation. 

• Understanding of medical and compliance, FDA, and regulatory guidelines (e.g., OIG, AMA, ACCME, Sunshine Act, etc.) 

• Experience with Management Platforms (Veeva, Salesforce, etc.) 

• Effective written, verbal and presentation skills

Benefits: Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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