Senior Research Assistant – Health Policy & Management
John Hopkins University
Associate Principal Scientist, Regulatory Affairs
Simplify
full-time
Posted on:
Location Type: Hybrid
Location: Jersey City • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $125,400 - $213,100 per year
Job Level
JuniorMid-Level
About the role
- Serve as the CMC Product Lead for assigned products
- Lead development and execution of global product and project regulatory strategies
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components
- Provide regulatory leadership to product in-license/due diligence review
- Collaborate with Organon Manufacturing & Supply colleagues and external partners for compliant execution of change management
- Assess and communicate potential regulatory risks and propose mitigation strategies
- Deliver all regulatory milestones for assigned products across the product lifecycle
Requirements
- Bachelor’s degree in a science, engineering, or a related field
- At least seven years of relevant experience including biological/pharmaceutical research, manufacturing, analytical testing or a related field OR advanced degree with at least four years of relevant experience
- Proven experience in critically reviewing detailed scientific information
- Demonstrated superior oral and written communication skills in multicultural settings
- Strong listening skills
- Demonstrated understanding of related fields (e.g., manufacturing, analytical, quality assurance)
- Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines
Benefits
- Health benefits including medical, prescription drug, dental, and vision coverage
- Paid vacation and holiday time
- Paid caregiver/parental and medical leave
- Retirement savings plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategiesCMC submission componentsbiological researchpharmaceutical researchmanufacturinganalytical testingquality assurance
Soft skills
leadershiporal communicationwritten communicationlistening skillscollaboration
Certifications
Bachelor’s degreeadvanced degree
