Sr. Manager, GRS Integration

The Senior Manager, GRS Integration will work closely with Global Regulatory Leads (GRLs), Country Regulatory Leads, Regulatory CMC Leads, and other regulatory and cross-functional partners to support the planning, coordination, and execution of regulatory activities across assigned programs. The role is responsible for helping translate regulatory strategy and program priorities into coordinated plans, timelines, milestones, and deliverables, while maintaining visibility to dependencies, risks, and upcoming regulatory commitments.

Here's What You'll Do

• Support one or more assigned programs, partnering closely with Global Regulatory Leads, Country Regulatory Leads, Regulatory CMC Leads, and other regulatory team members to develop, maintain, and execute integrated regulatory plans.
• Translate agreed regulatory strategy and program priorities into actionable plans, milestones, deliverables, timelines, dependencies, and ownership, ensuring regulatory activities remain coordinated across development, registration, and post-marketing stages.
• Actively manage regulatory plans, trackers, dashboards, and related planning tools to maintain current and accurate visibility into program milestones, risks, deliverables, dependencies, and upcoming decision points.
• Facilitate regulatory team meetings and planning discussions, ensuring decisions, risks, actions, and follow-up activities are clearly captured, assigned, and progressed.
• Proactively identify timeline risks, gaps, dependencies, and operational challenges; partner with regulatory leads to assess impacts, develop mitigation plans, support scenario planning, and escalate issues when appropriate.
• Support planning and readiness for major regulatory activities, including submissions, health authority interactions, responses to questions, CMC regulatory activities and variations, and country-specific regulatory requirements.
• Contribute to continuous improvement and cross-program initiatives that strengthen GRS Integration processes, tools, data quality, planning practices, visibility, and operational consistency.

Here's What You'll Bring to the Table

• BA/BS degree in a scientific, engineering, healthcare, business, or related discipline required; advanced degree and/or project management certification is a plus.
• Minimum of 5 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with relevant experience in regulatory project/program management, regulatory operations, drug development, or a closely related function.
• Experience supporting regulatory planning and execution across one or more stages of product development, registration, and/or post-marketing activities.
• Understanding of regulatory development processes and the activities required to support regulatory submissions, health authority interactions, approvals, and ongoing regulatory commitments.
• Knowledge of U.S. regulatory requirements with exposure to international regulatory requirements and global development activities.
• Demonstrated ability to coordinate complex deliverables, timelines, and dependencies across multiple stakeholders in a matrixed organization.
• Experience supporting regulatory submissions and familiarity with regulatory documentation and eCTD submission processes.
• Ability to manage more than one program or workstream at a time while maintaining appropriate prioritization, organization, and follow-through.
• Strong project management, organizational, and facilitation skills.
• Effective communication and influencing skills, with the ability to work collaboratively with Global Regulatory Leads, Country Regulatory Leads, Regulatory CMC Leads, and cross-functional stakeholders.
• Demonstrated ability to identify risks and issues, seek appropriate guidance, escalate when needed, and drive agreed actions to completion.
• Ability to operate effectively in a dynamic environment with changing priorities, evolving program needs, and competing timelines.
• Strong proficiency with project management, planning, and collaboration tools and an interest in using technology to improve regulatory planning, visibility, and execution.
• A collaborative, accountable, and continuous-improvement mindset, with the ability to work independently where appropriate while recognizing when alignment, guidance, or escalation is needed.