Senior Director Global Regulatory Advertising
Found in: Resume Library US A2 - 1 week ago
Location: This role is remote in the United States with occasional travel to Sobi sites for business-critical meetings/events. Candidates on the US East coast prefered.
The Senior Director Global Regulatory Advertising & Promotion will report to the Head of the Global Regulatory Compliance, Operations, Labeling and AdPromo (COLAP) and have accountability for 3 direct reports, the review and approval of U.S. promotional, corporate, and medical communications of assigned brand(s), and be the owner of the Global Review Process (GRP).
The role is a core member of the COLAP LT. The role is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA and will be responsible to function as a leader during review and elevation meetings to assure compliance with and evolution of the applicable Review Committee (RC) process enabling business needs to be met in a compelling, compliant, and timely way.
This position requires frequent interaction and strong collaboration with cross-functional partners for the purpose of providing regulatory advice and guidance through the product life cycle assuring conformity with applicable laws, regulations and Sobi policies.
Key Responsibilities
Responsibilities include, but are not limited to, the following:
Provides vision, strategy and leads the Regulatory Reviewers reporting into them
Oversees and directs the Regulatory Reviewers in assessing regulatory context and provide regulatory interpretations of applicable guidance and/or regulations or regulatory precedents
Demonstrates leadership as the Regulatory Advertising and Promotion Leader on the COLAP LT
Business owner of the Global Review Process and provides Regulatory advice and guidance on Advertising and Promotion for Global Commercial and Medical materials
Serve as an internal subject matter expert on FDA Advertising & Promotion issues for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations
Provides regulatory training as needed on applicable laws, regulations and Sobi policies, and leadership on assigned RC with respect to best practices in compliance with company policies and guidelines for RC processes. Demonstrate leadership as the regulatory reviewer on RC(s)
Develop SOPs and work instructions to facilitate streamlined workflows and encourage proficient practice of processes
Manage interactions with OPDP/APLB, including response to regulatory inquiries, and as needed, discussion with OPDP/APLB staff
Foster a healthy business partnership environment with stakeholders to ensure company meets strategic business objectives
Lead SRC teams in management of tasks that help support compliant execution of tactics and programs through the product’s life-cycle
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