Senior Manager Submissions Strategy at Pfizer focusing on regulatory submissions and compliance timelines. Directing projects and collaborating with cross-functional teams to ensure adherence to guidelines.
Responsibilities
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, leveraging expertise to develop strategic plans, resolve challenges, and drive teams towards objectives.
Providing strategic direction to teams on regulatory logistics and serving as a regulatory operational liaison on the project team.
Driving global submission management activities for assigned assets and providing guidance for related activities.
Promoting the use of Document Management and Archival systems and standard document authoring.
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 and maintain compliance with regulatory obligations.
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.
Experience in the pharmaceutical or biotechnology industry with advanced knowledge of regulatory guidelines and compliance standards (preferred).
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