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
Job title
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