Hybrid Senior Manager, Global Regulatory Diagnostics Strategy – Oncology

Posted 4 weeks ago

Apply now

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

Job title

Senior Manager, Global Regulatory Diagnostics Strategy – Oncology

Job type

Experience level

Senior

Salary

$135,100 - $225,100 per year

Degree requirement

Bachelor's Degree

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job