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pediatrics regulatory strategy regulatory compliance fda interactions📋 Description
- Develop US/global regulatory strategies for oncology programs
- Lead regulatory submissions planning and execution
- Advise cross-functional teams on regulatory pathways
- Ensure compliance with laws, regs, and guidances
- Provide strategic regulatory input for development documents
- Conduct regulatory intelligence to inform teams
🎯 Requirements
- 10+ years pharma/biotech with 5+ regulatory experience
- PharmD/MS preferred or Bachelors in life science
- Experience leading IND/CTA submissions
- NDA/MAA experience; post-approval labeling a plus
- Excellent written and verbal communication; detail-oriented
- Experience interacting with FDA/other agencies; US/EU landscape
🎁 Benefits
- Career advancement opportunities
- Competitive compensation with equity and bonus
- 401K + employer contributions
- Generous stock options and ESPP
- PTO and holidays (20 days; 18 holidays)
- Office perks: lunches, home office setup, commuter stipend
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