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← Pulmovant

Senior Manager, Regulatory Affairs, Pulmovant

Pulmovant
Location
Remote, US
Posted
26 days ago
Department
Regulatory
What they actually want (must-haves)
  • BS degree in a scientific field with 7 years of experience in regulatory affairs, or MS degree with 5 years, or PhD/PharmD with 3 years
  • Experience working with the FDA
  • Excellent communication and interpersonal skills
  • Ability to multi-task in a fast-paced environment
  • Highly proficient using Microsoft Office applications
  • Strong financial business acumen and analytical skills
Nice to have
  • Experience with EU, Japan, and other global health authorities
  • Experience interacting with the FDA Division of Cardiology and Nephrology
  • Experience with pulmonary hypertension and other pulmonary diseases
  • Regulatory Affairs Certification (RAC) in drugs and/or devices
  • Experience with global clinical trials using a CRO
What the job really is

The Senior Manager of Regulatory Affairs at Pulmovant will be responsible for executing global regulatory strategies and ensuring compliance throughout the clinical development process. This role involves representing Regulatory Affairs in project meetings, preparing regulatory submissions, liaising with health authorities, and developing internal policies. The position requires collaboration with cross-functional teams and external parties to support clinical trials and product registration.

Things to weigh
  • Remote position may require coordination across different time zones
  • Travel up to 10% may be required
  • No specific salary or benefits information provided
Job score2.6/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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