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Senior Manager, Regulatory Affairs Labeling

Mirum Pharmaceuticals
Location
Foster City
Posted
16 days ago
Department
Regulatory Affairs
Salary
$175,000 to $195,000
What they actually want (must-haves)
  • Bachelors or advanced degree in a scientific discipline
  • 3-6 years of regulatory labeling experience in the biopharmaceutical industry
  • Experience with writing, developing, and maintaining product labeling in the US and EU
  • Experience representing Regulatory Affairs Labeling on cross functional teams
  • Excellent verbal, written, negotiation, influence and interpersonal communication skills
  • Ability to work independently and in a team environment
Nice to have
  • Experience around the globe including LATAM, Middle East, and Asia-Pacific
  • Experience with using Veeva Vault RIM and QualityDocs
  • Resilient profile with the ability to deliver in an ambiguous environment
  • Strong team player that is solution oriented
  • Process oriented to achieve the business objective
What the job really is

The Senior Manager, Regulatory Affairs Labeling at Mirum Pharmaceuticals will be responsible for developing and managing global regulatory labeling strategies for marketed and developmental products. This role involves creating and updating labeling content, conducting competitor research, leading the Label Working Group, and ensuring compliance with local regulations. The position requires collaboration with various internal and external stakeholders to support labeling projects and maintain awareness of relevant regulations.

Benefits
  • Salary range of $175,000 to $195,000 USD
  • Compensation determined based on skill set, years of experience, and geographic location
  • Flexible work schedule that may include working outside of regular business hours
  • Hybrid work environment
Things to weigh
  • Fast-paced, high growth environment may require adaptability
  • Some travel required
  • No specific mention of additional benefits beyond salary range
  • Responsibilities may require working outside of regular business hours
Job score4/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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