Michelle Cholewa
Director Portfolio Planner
- Role
- Director at Pfizer
- Location
- Fernandina Beach, FL, US
- LinkedIn followers
- 500 followers
About Michelle Cholewa
CAREER SUMMARYResearch and Development (R&D) professional experienced in the pharmaceutical industry, primarily in the field of regulatory submissions. Currently, a Project Planner in Oncology. Previous experience as a US Regulatory Strategy Lead supporting the Oncology pipeline at Pfizer. Responsible for filing of various submission types (ie, IND/NDA, query response, labeling updates, annual reports, etc.) to the FDA. Coordination of responses and adherence to timelines in a fast paced regulatory environment. Serve as a liaison between other lines within Pfizer globally. Review performance standards and serve a critical role in technology, process improvement, and other operational initiatives that are related to or interface with the regulatory submission processes/systems.
Experience
Director
Oct 2024 — Present · US
Professional with regulatory submission and project management experience across all verticals with international exposure. Knowledgeable, self-motivated, experienced, clinical trial coordinator, and health care professional. Leadership strengths include multitasking and team coordination, timeline management, project leadership organization, and quality workmanship. Strong regulatory background includes knowledge of current EMA/FDA regulations, SOP preparation, and streamlining of procedures.
Education
Eastern Connecticut State University
B.S, Business Management/Computer Science
2003 — 2007
Temple University
Masters in Science, Regulatory Affairs/Quality Assurance
2007 — 2013
Skills
- Computer System Validation
- Workshop Facilitation
- Pharmaceutical Industry
- Sop
- Fda
- Drug Safety
- Biotechnology
- Glp
- Regulatory Submissions
- Validation
- Pharmacokinetics
- Electronic Common Technical Document (Ectd)
- Regulatory Affairs
- Regulatory Requirements
- Ectd
- Ind
- Change Control
- Negotiation
- U.s. Food and Drug Administration (Fda)
- Drug Discovery
- Clinical Development
- Report Writing
- Software Documentation
- Pharmacology
- Pharmacovigilance
- Quality Control
- Drug Development
- Gcp
- Biopharmaceuticals
- Networking
- Vaccines
- Nda
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