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Pfizer
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Groton, Connecticut
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fulfil Pfizer's regulatory commitments.
ROLE RESPONSIBILITIES
The RWE Platform ... ) regulatory document, study report, and publication preparation and review, and 6) clinical study
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Pfizer
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Groton, Connecticut
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Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, Market Access, Business Assessment & Development ... a trusted expert as assigned with study / analytical KOLs, key regulatory agencies (e.g., FDA in the
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Pfizer
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Groton, Connecticut
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aspects of drug development, also comfortable in discussing commercial and regulatory issues ... regulatory agencies (FDA, EMA, MHRA, etc.) regarding pharmaceutical indication and/or labeling issues
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Pfizer
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Groton, Connecticut
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for public disclosure. Subject to further legal review and statutory or regulatory clarification
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Pfizer
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Groton, Connecticut
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effectiveness which are pivotal to fulfil Pfizer's regulatory commitments.
**ROLE RESPONSIBILITIES ... and communication, 5) regulatory document, study report, and publication preparation and review, and 6
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Pfizer
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Groton, Connecticut
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markets, where the evidence will be used to respond to regulatory commitments / requests, HTA/government ... experience,
Experience assisting regulatory experts with new drug applications with FDA and EMA
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Pfizer
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Groton, Connecticut
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and regulatory submissions.
Provides statistical input to study designs and can contribute to ... of results, and collaborate on the reporting of clinical trial results to regulatory authorities and
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Pfizer
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Groton, Connecticut
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, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification
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Pfizer
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Groton, Connecticut
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, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process ... diverse needs of different regulatory requirements of different sites and countries.
Ability to lead
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Pfizer
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Groton, Connecticut
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regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed
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