A Regulatory Affairs Manager plans, directs, or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.
We are working with a leading pharmaceutical organization to support a high-priority promotional review function that keeps commercial activity aligned with regulatory standards. This position is a strong fit for a seasoned reviewer who can bring sound judgment, clear rationale, and cross-functional confidence to a fast-moving environment.
Responsibilities:
Conduct detailed regulatory review of promotional materials for healthcare professionals, direct-to-consumer campaigns, sales training, disease awareness, unbranded initiatives, and corporate content. Evaluate claims for consistency with approved labeling, supporting data, company policy, and applicable FDA advertising and promotion requirements. Participate in cross-functional promotional review committees and provide clear, well-supported regulatory input for time-sensitive business needs. Support evolving promotional compliance activities, including review considerations tied to CFL, SIUU, and products approved under Accelerated Approval.
Required:
10+ years of hands-on experience in regulatory advertising and promotional review within the pharmaceutical or biotechnology industry. Significant Ad Promo / promotional regulatory review experience . Recent experience independently reviewing PRC materials . Ability to provide regulatory input without significant supervision. Strong regulatory judgment and ability to determine when to escalate. Experience participating in PRC discussions/reviews. Ability to ramp up quickly and operate independently. Strong communication and proactive follow-through. Sufficient depth of experience — 1-3 years of Ad Promo experience is not considered ideal.
About SSI People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
