7h ago

Sr. Director, Global Regulatory Affairs Labeling

United States

$220k-$300k / yearest.

full-timedirector Remotebiotech

💼 About This Role

You'll lead the Global Labeling function at a rare disease-focused biopharma company, overseeing strategy and operations for products in development through commercialization. You will drive alignment with health agency regulations and ensure labeling compliance globally. This role offers the chance to build and mentor a team while making a meaningful impact on patients' lives.

🎯 What You'll Do

  • Lead the Global Labeling function as internal expert on health agency regulations.
  • Oversee labeling process for all programs from development through commercialization.
  • Author draft labeling texts (USPI, EU SmPC, etc.) for marketing applications.
  • Chair labeling approval process with Senior Management to drive cross-functional alignment.

📋 Requirements

  • Minimum 12 years experience in biotech/pharma with extensive global labeling.
  • Strong knowledge of global labeling regulations in US and EU.
  • Ability to develop innovative approaches to achieve commercial goals.
  • Excellent writing skills to summarize scientific data for labeling.

✨ Nice to Have

  • Advanced scientific degree (MSc, PhD, or PharmD).
  • Rare disease experience is desirable.

🎁 Benefits & Perks

  • 🏖️ Annual bonus and equity compensation.
  • 🏥 Health insurance (implied typical for industry).

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

  1. 1Recruiter Screen· 30 min
  2. 2Hiring Manager Interview· 45 min
  3. 3Panel Interview· 1 hour
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