Director, Regulatory Advertising and Promotion

We are seeking a highly skilled professional for a pivotal role in Regulatory Affairs, working within a dynamic cross-functional team. This position is responsible for the review and approval of compliant promotional and non-promotional communications aimed at educating healthcare professionals and consumers about our marketed products, pipeline, and related diseases. The ideal candidate will serve as a subject matter expert on FDA regulations and guidance documents related to prescription drug advertising and promotion. As the lead Regulatory reviewer in the Promotional Review Committee (PRC), you will oversee launch materials, U.S. marketed products, and non-promotional pre-approval communications. Additionally, you will participate in the review of scientific materials within the Medical Review Committee (MRC) as needed. Your role involves evaluating regulatory contexts and providing interpretations of relevant regulations, guidance, or precedents, while maintaining up-to-date knowledge on FDA laws and regulations. You will build and maintain strong working relationships with the FDA and internal colleagues in Regulatory Affairs, Medical Affairs, Legal, Commercial, and other cross-functional stakeholders.

Key Responsibilities

• Lead the implementation of promotional review strategies aligned with company goals.
• Provide expert regulatory advice for the development of compliant materials and activities related to new product launches, existing marketed products, development products, disease state education, field training, and external communications.
• Collaborate with Medical and Legal colleagues to review branded materials, ensuring promotional claims align with approved product labeling.
• Offer regulatory leadership in reviewing new claims, campaigns, and implementing product label changes into new and existing materials.
• Provide creative and compliant solutions to challenging promotional concepts, maintaining high standards of regulatory integrity and consistency.
• Provide strategic input on the preparation and submission of advertising and promotional materials to the Office of Prescription Drug Promotion (OPDP) and the Advertising, Promotional Labeling Branch (APLB), ensuring compliance with applicable laws and regulations.
• Work collaboratively with Regulatory Operations and Commercial Operations teams to ensure accurate, compliant, and timely regulatory submissions.
• Develop and maintain working relationships with OPDP/APLB staff, focusing on managing pre-submission requirements for accelerated approval products and advisory feedback requests.
• Interpret FDA feedback and communicate it promptly to stakeholders.
• Monitor changes in the regulatory environment and identify enforcement trends, providing training on FDA regulations to PRC teams and other stakeholders.
• Alert supervisors of potential risk mitigation discussions.
• Participate in developing, modifying, and executing company policies that affect immediate operations and have company-wide impacts.
• Enhance policies, standard operating procedures, best practices, and work instructions related to material review and approval management.

Qualifications

• Bachelor's degree or equivalent with 12+ years of related experience.
• Preferred experience in promotional review of rare disease and accelerated approval products.
• Extensive experience representing Regulatory on PRC teams and proficiency in advertising and promotional review (e.g., review of branded and non-branded materials).
• Prior experience consulting with OPDP and/or APLB review staff.
• Proven experience working with and successfully leading cross-functional teams.
• Exceptional collaboration, verbal, and written communication skills.
• Strong interpersonal skills with the ability to influence others without authority.
• Excellent organizational and negotiation skills.
• Strong analytical skills, problem-solving abilities, and strategic thinking; must be detail-oriented while analyzing the big picture.
• Ability to multitask, prioritize, and work under pressure to meet deadlines.
• Solid sense of accountability and sound judgment; highest ethical standards and a focus on quality and details.
• Experience working with and effectively communicating to stakeholders/partners at all levels, globally, across the organization.
• Ability to work in a fast-paced, matrixed environment.
• Proficiency with Microsoft Office Applications (Word, Excel, Outlook), Veeva, and other regulatory systems.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com

Qualifications

• Bachelor's degree or equivalent with 12+ years of related experience
• Extensive experience representing Regulatory on PRC teams and proficiency in advertising and promotional review (e.g., review of branded and non-branded materials)
• Prior experience consulting with OPDP and/or APLB review staff
• Proven experience working with and successfully leading cross-functional teams
• Exceptional collaboration, verbal, and written communication skills
• Strong interpersonal skills with the ability to influence others without authority
• Excellent organizational and negotiation skills
• Strong analytical skills, problem-solving abilities, and strategic thinking; must be detail-oriented while analyzing the big picture
• Ability to multitask, prioritize, and work under pressure to meet deadlines
• Solid sense of accountability and sound judgment; highest ethical standards and a focus on quality and details
• Experience working with and effectively communicating to stakeholders/partners at all levels, globally, across the organization
• Ability to work in a fast-paced, matrixed environment
• Proficiency with Microsoft Office Applications (Word, Excel, Outlook), Veeva, and other regulatory systems

Benefits

• In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law

Responsibilities

• This position is responsible for the review and approval of compliant promotional and non-promotional communications aimed at educating healthcare professionals and consumers about our marketed products, pipeline, and related diseases
• The ideal candidate will serve as a subject matter expert on FDA regulations and guidance documents related to prescription drug advertising and promotion
• As the lead Regulatory reviewer in the Promotional Review Committee (PRC), you will oversee launch materials, U.S. marketed products, and non-promotional pre-approval communications
• Additionally, you will participate in the review of scientific materials within the Medical Review Committee (MRC) as needed
• Your role involves evaluating regulatory contexts and providing interpretations of relevant regulations, guidance, or precedents, while maintaining up-to-date knowledge on FDA laws and regulations
• You will build and maintain strong working relationships with the FDA and internal colleagues in Regulatory Affairs, Medical Affairs, Legal, Commercial, and other cross-functional stakeholders
• Lead the implementation of promotional review strategies aligned with company goals
• Provide expert regulatory advice for the development of compliant materials and activities related to new product launches, existing marketed products, development products, disease state education, field training, and external communications
• Collaborate with Medical and Legal colleagues to review branded materials, ensuring promotional claims align with approved product labeling
• Offer regulatory leadership in reviewing new claims, campaigns, and implementing product label changes into new and existing materials
• Provide creative and compliant solutions to challenging promotional concepts, maintaining high standards of regulatory integrity and consistency
• Provide strategic input on the preparation and submission of advertising and promotional materials to the Office of Prescription Drug Promotion (OPDP) and the Advertising, Promotional Labeling Branch (APLB), ensuring compliance with applicable laws and regulations
• Work collaboratively with Regulatory Operations and Commercial Operations teams to ensure accurate, compliant, and timely regulatory submissions
• Develop and maintain working relationships with OPDP/APLB staff, focusing on managing pre-submission requirements for accelerated approval products and advisory feedback requests
• Interpret FDA feedback and communicate it promptly to stakeholders
• Monitor changes in the regulatory environment and identify enforcement trends, providing training on FDA regulations to PRC teams and other stakeholders
• Alert supervisors of potential risk mitigation discussions
• Participate in developing, modifying, and executing company policies that affect immediate operations and have company-wide impacts
• Enhance policies, standard operating procedures, best practices, and work instructions related to material review and approval management