This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:The Director of Advertising and Promotion Regulatory Operations is responsible for U.S. and global AdPromo operations supporting the review, approval, and regulatory submission of advertising and promotional materials.
This role provides operational oversight for systems, standards, metrics, process governance, FDA submissions for U.S. products, and related issue escalation. The successful candidate may also support select labeling operations activities as needed to advance departmental priorities.
Key Accountabilities:- Provide managerial oversight of the offshore Hub responsible for processing assigned regulatory submissions, including workload management, quality expectations, issue escalation, training needs, and adherence to submission timelines.
- Manage Hub performance through defined service expectations, key performance indicators, training and onboarding support, issue resolution, and routine performance reviews to drive consistent submission quality, operational efficiency, and continuous improvement.
- Lead end-to-end operational ownership of AdPromo submission activities, ensuring clear submission plans, resource allocation, timeline management, prioritization, performance metrics, process governance, issue escalation, operational risk mitigation, and inspection readiness to drive timely, accurate, compliant, and business-critical execution.
- Serve as the point of contact for written and verbal communications with FDA regarding technical submission issues related to advertising and promotional materials.
- Provide direction and quality control oversight for the submission of promotional materials to FDA on Form 2253.
- Apply quality management principles to maintain departmental Quality Documents and ensure compliance with FDA regulations and guidance, applicable country regulations, and company standards.
- Partner with commercial teams and cross-functional stakeholders to develop practical, compliant solutions for complex regulatory submissions, applying the technological and operational expertise needed to support rapid, informed decisions aligned with business objectives.
- Monitor AdPromo submission and review processes to ensure ongoing compliance with Health Authority requirements, company standards, guidelines, and regulations. Support internal and external audit readiness, deviation investigations, and corrective and preventive actions, while identifying opportunities to strengthen controls, improve process efficiency, and maintain high-quality promotional materials.
Who You Are:Minimum Requirements- Bachelor's degree in a science, or health- related, or relevant discipline.
- Minimum 8 years of pharmaceutical industry or related experience, with an emphasis in regulatory operations, promotion quality or label operations.
- Minimum 4 years of direct experience in regulatory submission of promotional material.
- In-depth understanding of FDA regulations, processes, and systems related to advertising and promotion.
- Exercise a high degree of understanding of the clinical development process, including labeling development and approval processes.
- Demonstrated ability to identify solutions to complex promotional regulatory submission issues.
- Strong interpersonal skills with the ability to influence, collaborate, and demonstrate strategic and analytical thinking.
- Proactive and solution-oriented with the ability to manage multiple priorities simultaneously.
- Proficiency in Microsoft Excel, PowerPoint, and AI-enabled tools used to support operational reporting, process improvement, and decision-making.
- Excellent verbal and written communication skills.
Location: Boston, MA preferred; Open to Remote
Travel:Pay Range for this position: $183,400.00 - $275,000.00
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
