Chief Compliance Officer ensuring compliance with BSP regulations for the first crypto brand in the Philippines. Managing risk compliance, policies, and providing guidance to teams.
PF
Hybrid Senior Manager, Global Regulatory Diagnostics Strategy – Oncology
Posted 5 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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LA
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