Senior Regulatory Program Manager
New
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LifelancerLife sciences
Remote, North Carolina, USAFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management.
- Required Skills
- Microsoft Office SuitePowerPoint
Requirements
- Hold a BA/BS degree in a scientific, engineering, or healthcare discipline.
- Bring at least 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry.
- Have at least 5 years of experience in regulatory or regulatory program management.
- Demonstrate experience partnering on regulatory strategy and leading execution across product development, IND/BLA/MAA submissions, global registration, and post-marketing activities.
- Have a deep understanding of U.S. regulatory requirements and working knowledge of international regulations and agency expectations.
- Have experience managing complex regulatory deliverables across cross-functional teams in a matrixed organization.
- Have hands-on eCTD experience and strong knowledge of regulatory documentation, formatting, and submission strategy.
- Demonstrate experience facilitating cross-functional meetings, structuring agendas, documenting decisions and actions, and tracking follow-up.
- Have expert skills in Smartsheet and Microsoft Office Suite.
- Be expert at creating visuals using PowerPoint and timeline integration tools such as One Pager or Office Timeline Pro.
- Be a proficient user of Veeva Regulatory Information Management (RIM).
- An advanced degree (MS, PharmD, or PhD) and/or PMP certification is strongly preferred.
Responsibilities
- Partner with Global Regulatory Leads to shape and execute global regulatory plans across development and post-marketing.
- Translate regulatory strategy into plans with milestones, critical paths, risks, and opportunities.
- Lead execution of regulatory plans and align operational work with program objectives.
- Identify regulatory pathways and planning scenarios aligned with regulatory expectations and business objectives.
- Coordinate cross-functional stakeholders on regulatory deliverables, timelines, and interdependencies.
- Facilitate GRST meetings and project review forums, including agendas, action logs, decisions, and follow-up.
- Maintain GRST governance, meeting cadence, stakeholder alignment, and communication across global and regional teams.
- Anticipate and resolve regulatory project challenges and improve processes and submission readiness.
- Prepare dashboards, reports, and scenario plans for senior stakeholders.
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