Senior Program Director, Commercial Regulatory Affairs

Jobtailor; Deutschland; Vor Ort; EUR 90.000 - 140.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an accomplished Regulatory Affairs professional to lead Promotional Review Committee (PRC) meetings and to guide the review and approval of promotional and marketing materials in the biotech/pharmaceutical sector.

This role provides regulatory guidance on advertising claims, ensures compliance with FDA advertising and promotion rules, and partners with Marketing, Medical, Legal and Compliance teams to align on messaging and risk.

Qualifikationen

• Bachelor's degree required; advanced degree preferred.
• 7+ years in Regulatory Affairs, Compliance or Advertising & Promotion in biotech/pharma.
• Strong knowledge of FDA advertising and promotion regulations.
• Experience leading cross-functional teams and PRCs.
• Excellent communication and stakeholder management.

Aufgaben

• Lead Promotional Review Committee (PRC) meetings.
• Review and approve promotional and marketing materials.
• Provide regulatory guidance on advertising claims.
• Partner with Marketing, Medical, Legal, and Compliance teams.
• Support FDA communications and Form 2253 submissions.
• Ensure compliance with FDA regulations and healthcare guidelines.

Kenntnisse

Regulatory affairs

Advertising & promotion

Cross-functional leadership

Stakeholder management

Project leadership

Ausbildung

Bachelor's degree

Advanced degree preferred

Jobbeschreibung

Responsibilities

• Lead Promotional Review Committee (PRC) meetings
• Review and approve promotional and marketing materials
• Provide regulatory guidance on advertising and promotional claims
• Partner with Marketing, Medical, Legal, and Compliance teams
• Support FDA communications and Form 2253 submissions
• Ensure compliance with FDA regulations and healthcare industry guidelines

Requirements

• Bachelor's degree required; advanced degree (PharmD, PhD, JD, MBA, MS) preferred
• 7+ years of Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion experience in the biotech/pharmaceutical industry
• Strong knowledge of FDA advertising & promotion regulations, promotional review, and healthcare compliance
• Experience leading cross-functional teams and Promotional Review Committees (PRCs)
• Excellent communication, stakeholder management, and project leadership skills.

Core Competencies

Demonstrates expertise in Regulatory Affairs and Compliance within the biotech and pharmaceutical industries, with a strong focus on FDA advertising and promotion regulations. Proven ability to lead cross-functional teams and manage promotional review processes effectively.