Senior Clinical Trial Submission Manager
Pfizer
full-time
Posted on:
Location Type: Remote
Location: Poland
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Salary
💰 PLN 249,750 per year
Job Level
About the role
- directing the development, quality control and publication of submissions relating to asset development and registration
- driving adherence to external regulatory guidelines and compliance timelines for multiple submission types
- leading complex projects division-wide
- developing strategic plans, resolving challenges, and driving teams towards achieving objectives
- providing strategic direction to teams on regulatory logistics
- serving as a regulatory operational liaison on the project team throughout the product lifecycle
- driving global submission management activities for assigned assets
- partnering with product teams and/or third-party partners to manage required regulatory activities
- promoting the use of Document Management and Archival systems and standard document authoring
- driving communication and proposing refinements for the emerging markets through collaboration with stakeholders
- leading the interpretation of regulatory guidelines and requirements to produce business processes and ensuring implementation
- partnering with key stakeholders to ensure quality and consistency of processes
Requirements
- BA/BS with 6+ years of experience, or MBA/MS with 5 + years of experience, or PhD/JD with 1+ years of experience, or MD/DVM with 0+ years of experience.
- Extensive knowledge in drug development, Regulatory Affairs, and submission management.
- Advanced Microsoft Office Suite skills and strong competency with tools.
- Strong understanding of regulatory submission processes and requirements.
- Excellent analytical and problem-solving abilities.
- Effective communication skills, both written and verbal.
Benefits
- company car
- Medicover
- Multisport
- insurance at UNIQUA
- provate pension plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairssubmission managementdrug developmentregulatory submission processesquality controlstrategic planningproject managementanalytical skillsproblem-solving
Soft skills
effective communicationleadershipcollaborationteam management
Certifications
BABSMBAMSPhDJDMDDVM