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Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Nurix
Location
Brisbane, California, United States
Posted
13 days ago
Department
Regulatory
Salary
$187,800 - $208,638
What they actually want (must-haves)
  • Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred
  • Minimum of 8 years in Regulatory affairs strategy
  • Strong knowledge of drug development, FDA, EMA and ICH guidelines and regulations
  • Experience with planning clinical trial and marketing applications to health authorities including FDA, EMA
  • Ability to read, analyze and interpret scientific and technical information
  • Proven track record in supporting Regulatory affairs for major filings and ongoing maintenance of clinical trial and marketing applications
What the job really is

The Senior Manager/Associate Director of Regulatory Affairs will play a key role in developing and executing global regulatory strategies for hematology oncology products. Responsibilities include providing regulatory direction, assisting with clinical trial compliance, preparing regulatory submissions, and collaborating with cross-functional teams to ensure product compliance throughout the development lifecycle.

Things to weigh
  • Onsite work required in Brisbane, CA
  • Salary range provided for two levels (Senior Manager and Associate Director) but no details on specific benefits or perks are mentioned.
Job score3.8/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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