Consultant for GMP compliance and quality assurance in Life Sciences. Engage in validation projects and assist in compliance documentation.
PF
Hybrid Senior Manager, Global Regulatory Diagnostics Strategy – Oncology
Posted 2 months ago
About the role
- Senior Manager managing regulatory diagnostics strategy for oncology at Pfizer. Leading teams in clinical development interaction with regulatory agencies to expedite approval processes.
Responsibilities
- 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
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