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
- Assist 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
- Be the diagnostic regulatory liaison on the project team throughout the product lifecycle
- Support the 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
- Provide guidance to operational teams for managing projects with diagnostics components
- Prepare forecasts for resource requirements and improve products, processes or services
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
- Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include 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 experienceEU IVDR submission processesEU CTR submission processesIVDR requirementsNew Drug Application (NDA)Investigational New Drug (IND)US device submissionsIDE510(k)PMA
Soft skills
leadership qualitiesmanagement skillsteam orientedproblem solving skillsstrong written communicationstrong verbal communicationinterpersonal skills
