Regulatory Affairs Specialist, Promotional Review- Remote

Hydrogen Group; San Francisco (CA); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking an experienced Regulatory Affairs Specialist to coordinate promotional submissions ensuring compliance with FDA regulations. The ideal candidate will have over 3 years of experience in regulatory operations and strong knowledge of submission processes. This role requires excellent organizational skills and effective communication with cross-functional teams.

Qualifications

• 3+ years of experience in regulatory operations, promotional review, or submissions coordination.
• Strong knowledge of FDA Subpart H regulations and submission requirements.
• Highly organized and detail-oriented.

Responsibilities

• Coordinate ad-promo submissions ensuring accuracy and compliance.
• Support process improvements and maintain documentation.
• Liaise between departments to ensure streamlined submission readiness.

Skills

Regulatory operations coordination

FDA compliance knowledge

Process management

Excellent communication skills

Problem-solving

Tools

Veeva Vault PromoMats

Job description

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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