Senior Manager Regulatory Affairs

2 weeks ago


Palo Alto, California, United States Ascendis Pharma Full time
Job Summary

We are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team at Ascendis Pharma. This role will be responsible for supporting and developing global regulatory strategies for our oncology pipeline products.

Key Responsibilities
  • Develop and implement global regulatory strategies for oncology pipeline products
  • Prepare and manage submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs
  • Maintain knowledge of highly complex regulatory requirements and communicate changes to project teams
  • Lead teams in preparation of investigational and marketed products submissions
  • Review technical documents and influence colleagues across functions
Requirements
  • BS/BA Degree in a Scientific Discipline, Advanced degree desirable
  • Minimum of 8 years of direct regulatory affairs experience in the biopharmaceutical industry
  • Oncology regulatory experience a plus
  • Ability to travel up to 10% of the time domestically
What We Offer
  • Competitive salary range: $150-165K/year
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • 401(k)
  • Paid maternity leave
  • Paid paternity leave
  • Commuter benefits
  • Disability insurance


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