[Remote] Executive Director / Director – Regulatory Affairs (Ad Promo)
Note: The job is a remote job and is open to candidates in USA. KPG99 INC is seeking a highly experienced Executive Director/Director of Regulatory Affairs specializing in Advertising & Promotion. This role involves serving as the primary regulatory reviewer for promotional and corporate communication materials, requiring deep expertise in FDA Ad Promo regulations and collaboration with legal and medical review teams.
Responsibilities
• Act as the primary regulatory reviewer for promotional and corporate communication materials
• Conduct hands-on reviews within Veeva , ensuring accuracy, compliance, and consistency
• Serve as an SME on promotional review standards , ensuring alignment with product labeling, label changes, and FDA regulatory guidance
• Collaborate closely with Legal, Medical, and cross-functional stakeholders during review cycles
• Review materials for compliance with FDA Ad Promo requirements, including risk/benefit balance and fair presentation
• Prepare, review, and submit materials to OPDP (strong preference)
• Proactively identify risks, raise concerns, and take ownership as a consultant-level contributor
• Support escalation discussions and provide clear regulatory recommendations
Skills
• 10+ years of Regulatory Affairs experience with a strong focus on Advertising & Promotion
• Very hands-on background (not advisory-only)
• Proven experience reviewing promotional materials in Veeva
• Prior experience as a main/lead regulatory reviewer
• Strong knowledge of FDA regulations and guidance related to promotional communications
• Excellent communication, collaboration, and professional judgment skills
• Ability to work independently in a consultant capacity and confidently raise issues when needed
• Experience submitting materials to OPDP
Company Overview
• Our business consulting services are led by significant domain depth built on a robust technology-driven services platform. It was founded in 2013, and is headquartered in Hampton, New Jersey, USA, with a workforce of 51-200 employees. Its website is https://www.kpg99.com/.
Apply Now
Apply Now
Responsibilities
• Act as the primary regulatory reviewer for promotional and corporate communication materials
• Conduct hands-on reviews within Veeva , ensuring accuracy, compliance, and consistency
• Serve as an SME on promotional review standards , ensuring alignment with product labeling, label changes, and FDA regulatory guidance
• Collaborate closely with Legal, Medical, and cross-functional stakeholders during review cycles
• Review materials for compliance with FDA Ad Promo requirements, including risk/benefit balance and fair presentation
• Prepare, review, and submit materials to OPDP (strong preference)
• Proactively identify risks, raise concerns, and take ownership as a consultant-level contributor
• Support escalation discussions and provide clear regulatory recommendations
Skills
• 10+ years of Regulatory Affairs experience with a strong focus on Advertising & Promotion
• Very hands-on background (not advisory-only)
• Proven experience reviewing promotional materials in Veeva
• Prior experience as a main/lead regulatory reviewer
• Strong knowledge of FDA regulations and guidance related to promotional communications
• Excellent communication, collaboration, and professional judgment skills
• Ability to work independently in a consultant capacity and confidently raise issues when needed
• Experience submitting materials to OPDP
Company Overview
• Our business consulting services are led by significant domain depth built on a robust technology-driven services platform. It was founded in 2013, and is headquartered in Hampton, New Jersey, USA, with a workforce of 51-200 employees. Its website is https://www.kpg99.com/.
Apply Now
Apply Now