Regulatory Project Manager
About The Position
The individual will support one or more global development programs as part of our Global Regulatory Science organization. The specific therapeutic area and program assignment will be determined based on the candidate’s experience, capabilities, and fit with the team. This individual will support across both early- and late-stage development programs. The role will partner closely with Global Regulatory Leads and cross-functional stakeholders to translate regulatory strategy into integrated, executable plans; manage key milestones, timelines, dependencies, risks, and regulatory deliverables; and help drive alignment and accountability across global regulatory teams. The individual will also support effective Global Regulatory Subteam governance, including meeting planning and facilitation, decision and action tracking, stakeholder communication, and follow-through on key regulatory activities. Candidates with strong experience supporting global regulatory development programs, with particular emphasis on the US, EU, Canada, Australia, and UK. Exposure to APAC and LATAM markets is desirable, although deep regional expertise in those geographies is not required.
Requirements
- Significant pharmaceutical or biotechnology experience, including substantial experience in regulatory affairs and/or regulatory program management.
- Experience supporting regulatory strategy and execution across development stages, including major submissions, global registration activities, and, where applicable, post-marketing activities.
- Strong project and program management capabilities, including management of complex timelines, interdependencies, risks, and cross-functional deliverables.
- Demonstrated ability to work effectively in a matrixed global organization and partner with senior regulatory and cross-functional stakeholders.
- Strong communication, facilitation, organizational, and influencing skills.
Nice To Haves
- Exposure to APAC and LATAM markets is desirable, although deep regional expertise in those geographies is not required.
- Familiarity with regulatory systems and tools; experience with Smartsheet, Microsoft Office/PPT-based timeline visualization tools, and Veeva RIM would be beneficial.
Responsibilities
- Translate regulatory strategy into integrated, executable plans
- Manage key milestones, timelines, dependencies, risks, and regulatory deliverables
- Drive alignment and accountability across global regulatory teams
- Support effective Global Regulatory Subteam governance, including meeting planning and facilitation, decision and action tracking, stakeholder communication, and follow-through on key regulatory activities
Benefits
- Incentive plans, bonuses, and/or other forms of compensation may be offered
- A range of health and welfare and/or other benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
