Regulatory Affairs Specialist-Ad Promo
We are seeking an experienced Regulatory Ad Promo Submissions Coordinator to support the planning, tracking, and execution of promotional material submissions in compliance with FDA regulations. This role ensures timely, accurate submissions while facilitating communication between regulatory, marketing, and agency partners.
Key Responsibilities
Promotional Submission Coordination
- Serve as the primary coordinator for ad-promo submissions, ensuring all materials are complete, accurate, and submitted on schedule.
- Collaborate closely with marketing teams and creative agencies to align on timelines and regulatory requirements.
- Track and manage submissions, including pre-clearance, accelerated, and FDA Form 2253 filings.
Process Management & Compliance
- Support implementation and improvement of submission processes, including checklists and tools to enhance tracking efficiency.
- Maintain detailed, audit-ready documentation to ensure compliance and inspection readiness.
- Align submission metadata and key dates to meet internal and regulatory standards.
Binder Creation & Documentation
- Compile promotional materials, prescribing information (PI), and supporting documentation into submission binders.
- Prepare draft submission forms, manage signature routing, and upload finalized documents for eCTD submission.
Cross-Functional Collaboration
- Act as a liaison between Regulatory Affairs, Regulatory Operations, Marketing, and external partners to streamline submission readiness.
- Partner with internal teams to complete necessary workflows in Veeva Vault PromoMats.
Qualifications
- 3+ years of experience in regulatory operations, promotional review, or submissions coordination within the pharmaceutical or biotech industry.
- Strong knowledge of FDA Subpart H regulations and advertising/promotion submission requirements, including FDA Form 2253.
- Proficiency with PromoMats or similar content approval systems.
- Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced environment.
- Proven problem-solving skills and ability to work independently.
- Excellent communication skills for effective cross-functional and external collaboration.
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