[Hiring] Global Clinical Trial Submission and Portfolio Senior Manager @Pfizer

Role Description

As a Senior Manager Submissions Strategy, you will:

• Direct the development, quality control, and publication of submissions relating to asset development and registration.
• Drive adherence to external regulatory guidelines and compliance timelines for multiple submission types.
• Lead complex projects division-wide, leveraging your expertise to develop strategic plans, resolve challenges, and drive teams towards achieving objectives.
• Provide strategic direction to teams on regulatory logistics and serve as a regulatory operational liaison on the project team throughout the product lifecycle.
• Drive global submission management activities for assigned assets and provide guidance for related activities.
• Partner with product teams and/or third-party partners to manage required regulatory activities.
• Promote the use of Document Management and Archival systems and standard document authoring.
• Drive communication and propose refinements for the emerging markets through collaboration with stakeholders.
• Lead the interpretation of regulatory guidelines and requirements to produce business processes and ensure implementation.
• Partner with key stakeholders to ensure quality and consistency of processes and maintain compliance with regulatory obligations.
• Serve as a source of innovative ideas, seeking and developing efficiencies within the Submissions process.
• Drive and implement strategies for operational excellence through interaction with global regulatory leaders and product teams.

Qualifications

• 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.

Requirements

• Experience in the pharmaceutical or biotechnology industry with advanced knowledge of regulatory guidelines and compliance standards.
• Strong understanding of statistical modeling and data analytic methodologies.
• Demonstrated knowledge of product lines, processes, and associated technologies.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance.

Benefits

• Company car
• Medicover
• UNIQA
• Multisport
• PPE at Goldman Sachs & other as per company policy