Senior Regulatory Affairs Consultant - Regulatory Project Manager
RemoteUnited States
Job Summary
Shape and execute globally aligned regulatory plans across all stages of development and post-marketing by partnering with Global Regulatory Leads. Translate strategy into actionable plans with clear milestones, critical paths, risks, and opportunities to support informed decision-making. Lead the execution of these plans, ensuring alignment between day-to-day operations and strategic objectives while identifying innovative regulatory pathways. Facilitate Global Regulatory Subteam meetings and project review forums, applying project management best practices to ensure structured agendas, documented decisions, and strong meeting hygiene. Anticipate complex operational challenges, implement scalable solutions, and prepare strategic dashboards to translate regulatory progress into actionable business insights for senior stakeholders. Drive regulatory excellence by aligning cross-functional teams and maintaining effective governance across global and regional markets.
Required Qualifications
- BA/BS degree in a scientific, engineering, or healthcare discipline
- Advanced degree (MS, PharmD, PhD)
- PMP certification
- Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry
- At least 5 years in regulatory or regulatory program management
- Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities
- Previous marketing application experience
- Deep understanding of U.S. and EU regulatory requirements
- Working knowledge of global regulations and agency expectations
- Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization
- Alignment to strategic priorities
- Hands-on experience with eCTD
- Strong command of regulatory documentation, formatting, and submission strategy
- Exceptional communication and influencing skills
- Ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders
- Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs
- Flexibility and strategic foresight
- Demonstrated ability to leverage project management tools and best practices
- Enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams
- Demonstrated experience facilitating cross-functional team meetings
- Driving structured agendas
- Documenting decisions and actions
- Maintaining strong meeting hygiene and team accountability in a matrixed environment
- Expert skills in Smartsheet (Regulatory Activity and Submissions Project Plans)
- Expert skills in Microsoft Office Suite
- Expertise in creating visuals using PPT generated from timeline integration tools (e.g., One Pager, Office Timeline Pro)
- Proficiency in Veeva Regulatory Information Management (RIM)
Desired Qualifications
- Advanced degree (MS, PharmD, PhD)
- PMP certification
- Experience supporting global development programs across multiple modalities or therapeutic areas
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