Delivery Manager leading and enabling high - performing Delivery teams for Pinewood.AI's Automotive Intelligence Platform. Focused on customer outcomes and value realization in the automotive industry.
About the role
- 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).
Benefits
- Flexibility
- Health insurance
- Disability Inclusion
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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