Senior Manager, Global Regulatory Diagnostics Strategy – Oncology
Pfizer
Senior Manager, Global Regulatory Diagnostics Strategy – Oncology
Pfizer
full-time
Posted on:
Location Type: Hybrid
Location: California, Connecticut, New York, Pennsylvania, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $135,100 - $225,100 per year
Job Level
Senior
About the role
- Represent Pfizer as an approval liaison in the regulatory affairs team assisting with diagnostics regulatory tasks
- Provide regulatory strategic direction to teams overseeing clinical development of products and diagnostics
- Interact with regulatory agencies and diagnostics partners, including negotiations to expedite regulatory approval of trials co-developing medicinal and diagnostic products
- Support submission of medicinal and diagnostic product registration, progress reports, supplements, amendments, and periodic reports
- Evaluate existing internal processes and procedures related to implementation of diagnostic regulations and support other functions to identify gaps
- Provide guidance to operational teams for managing projects with diagnostics components
- Develop and maintain tools to ensure tracking of projects, deliverables, and accomplishments
- Work in collaboration with stakeholders across the organization to deliver efficiencies in regulatory submissions and processes
Requirements
- Bachelor's Degree (higher degree preferred)
- 5+ years of relevant experience
- Demonstrable experience of effective delivery in a complex matrix environment
- Regulatory experience to include knowledge of EU IVDR/CTR submission processes and IVDR requirements
- Regulatory experience including knowledge of New Drug Application (NDA)/Investigational New Drug (IND) submission processes
- Regulatory experience including knowledge on US device submissions (IDE, 510(k), de Novo, PMA) and CAP/CLIA laboratory requirements
- In depth knowledge of national/regional regulatory legislation and guidelines
- Knowledge of pharmaceutical analytics technology, pharmacology, toxicology and medicine
- Leadership qualities and management skills, team oriented with problem solving skills
- Strong written and verbal communication and interpersonal skills
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental, and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsEU IVDR submission processesNew Drug Application (NDA)Investigational New Drug (IND)US device submissionsIDE510(k)de NovoPMApharmaceutical analytics technology
Soft skills
leadershipmanagementteam orientedproblem solvingstrong written communicationstrong verbal communicationinterpersonal skills
