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  • Regulatory Affairs Project Manager United States
  • EPM Scientific in United States, , United States
  • jobs
  • 2 weeks ago

jobs description

Introductory Paragraph:

Our client, a leading pharmaceutical company based in Maryland is seeking an experienced and highly motivated individual to join their team as the Regulatory Affairs Product Lead. The successful candidate will be responsible for overseeing all aspects related to small molecule drug development with specific experience within oncology...

Responsibilities:
• Develop and implement regulatory strategies that ensure compliance with FDA regulations
• Manage timelines associated with various stages of product development
• Collaborate cross-functionally throughout multiple teams including clinical operations, medical writing, pharmacovigilance among others.
• Prepare submissions required by health authorities such as INDs/CTAs/NDSs and NDA's

Qualifications & Skills:
• 7 years of pharmaceutical or biotechnology industry experience
• Minimum 5 years' industry experience relevant work history within Regulatory Affairs
• Bachelor’s degree or higher level education preferably majoring in pharmacy/sciences/biology/life sciences/pharmaceutical science.
• Demonstrate knowledge/experience using FDA guidelines/regulations
• Outstanding communication skills both written/oral
• Oncology experience is prefered
United States

salary-criteria

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