AD, Regulatory Project Manager
New
J
JobgetherPharmaceutical / Biotechnology
Based in the United StatesFull-TimeManager
SalaryBase salary typically ranging from $140,000 to $222,000, depending on qualifications, experience, skills, and other applicable factors.
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Job Details
- Experience
- At least 5 years of progressive experience in the pharmaceutical or biotechnology industry
- Required Skills
- Project ManagementAgile methodologiesStakeholder managementAsana
Requirements
- Bachelor's degree in a relevant discipline such as life sciences, pharmacy, chemistry, or Business Administration.
- At least 5 years of progressive experience in the pharmaceutical or biotechnology industry, preferably with a focus on project management.
- Significant experience managing complex projects, cross-functional teams, timelines, dependencies, and deliverables.
- Understanding of pharmaceutical development processes and regulatory submissions.
- Demonstrated understanding and practical application of project management processes, tools, tracking systems, and databases.
- Familiarity with project management platforms such as Microsoft Project, Asana, or comparable solutions.
- Strong understanding and application of Agile principles and practices.
- Strong critical-thinking and problem-solving abilities, with the capacity to influence, negotiate, resolve conflicts, and build alignment.
- Excellent communication and presentation skills.
- Advanced project management certification is preferred.
Responsibilities
- Translate regulatory strategy into actionable project plans, milestones, deliverables, timelines, dependencies, and accountabilities.
- Lead the planning and execution of complex regulatory projects and submissions, ensuring end-to-end delivery from preparation through submission, approval, and health authority feedback.
- Create and continuously update critical paths for regulatory submissions, incorporating internal and external events, dependencies, and key milestones.
- Track and report project performance metrics, including milestones, timelines, resourcing, documentation, submission progress, and KPIs.
- Coordinate Submission Deliverable Teams and Regulatory Excellence Team activities, ensuring effective collaboration, alignment, and accountability across stakeholders.
- Coordinate regulatory actions and deliverables from pre-IND through MAA submission, including Health Authority interactions and Clinical Trial Applications.
- Facilitate cross-functional problem-solving and encourage agile practices such as sprint planning, daily stand-ups, and retrospectives.
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