Staff Regulatory Affairs Specialist, Pharmaceuticals
Stryker
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $95,700 - $207,400 per year
Job Level
About the role
- support fluorescence imaging drug products used in combination with the Open and Minimally Invasive Visualization portfolios within the Endoscopy Business
- prepare complex submissions pertaining to pharmaceutical product approvals for clinical investigations, commercial distribution and/or new/expanded indications by FDA, Health Canada and other regulatory bodies
- assess post-approval changes to determine the regulatory filing category and ensure compliance by completing thorough regulatory assessments
- advise personnel on regulatory pathway option(s) and requirements
- support presentations to health authorities and any related communications
- support regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/ background, classification, disease, and/ or harmonized/ recognized standards
- assess the acceptability of quality, nonclinical and clinical documentation for submission filings to comply with regulatory requirements for clinical investigations and marketing applications and corporate goals
- prepare submissions and/ or documents supporting submissions (i.e., CTD summaries) to gain approvals for clinical investigations and/ or commercial distribution
Requirements
- Bachelor’s Degree
- 4+ years of experience in an FDA regulated industry
- 2+ years of pre- and/or post-market Regulatory Affairs experience
- Experience preparing submissions and/ or documents supporting submissions (i.e., CTD summaries) to gain approvals for clinical investigations and/or commercial distribution
- Ability to comply with constantly changing regulatory and clinical environments and prioritize work effectively
- Ability to understand and explain detailed regulatory compliance programs and/or issues
- Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment
Benefits
- bonus eligible 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords
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Hard Skills & Tools
regulatory submissionsCTD summariesregulatory assessmentsclinical investigationscommercial distributionpharmaceutical product approvalspost-approval changesregulatory filing categoryquality documentationnonclinical documentation
Soft Skills
communicationadaptabilityprioritizationproblem-solvinginterpersonal skillsorganizational skillsability to explain compliance programsability to thrive in dynamic environmentspresentation skillscollaboration
Certifications
Bachelor’s Degree