POSITION SUMMARY

The Director, Regulatory Project Management provides strategic leadership and oversight for the planning and execution for Regulatory Medical Writing (RMW) Department deliverables, including, high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, etc.), rare disease designations, major supplements/variations, and lifecycle submissions for assigned programs. This position will contribute to regulatory submission strategy, working in close collaboration with the RMW team, Global Regulatory Lead (GRL), as well as cross-functional teams to identify submission risks and opportunities, define regulatory deliverables, and build timelines/dashboards to support regulatory filings through licensure and beyond.

The Director also serves as a senior advisor to leadership, guiding decision-making, resource planning, and continuous improvement of RMW processes.

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for partnering across the RMW Department (Strategic Regulatory, CMC Regulatory, Labeling, Ad-Promo, Regulatory Information Management, and Medical Writing) and with cross-functional project teams to ensure regulatory timelines/strategies are developed and seamlessly executed upon, enabling successful filings with Global Health Authorities.
• Co-lead Global Regulatory Project Team (GRPT) meetings in partnership with GRL.
• Co-lead product/submission-specific multi-disciplinary Filing Teams – working with all major contributors to set expectations and ensure timelines are met.
• Develop/actively manage project timelines and integrated submission project plans to ensure timelines remain on schedule.
• Work with each function to understand individual deliverables and interdependencies between deliverables to create and maintain an overall project plan timeline across all Modules (Modules 1-5).
• Identify and communicate both regulatory and project risks – providing potential solutions to the cross-functional project team and leadership as needed.
• Prepare meeting agendas, meeting minutes and document decisions/action items/risk mitigation plans. Organize and maintain this team information in a central location.
• Prepare and distribute reports/trackers to communicate updates and project status.
• Proactively drive project/submission teams and establish an appropriate level of urgency with a keen focus on deliverables.
• Conduct lessons learned sessions to identify areas for improvement.
• Standardize processes/dashboards to manage overall, cross-portfolio RMW submission workload.
• Track overview of major submission and health authority activity to aid in Regulatory resource planning.
• Organize key aspects of the regular RMW Department on site activities as needed.
• Support the Head of Regulatory Project Management & Information Systems as required.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent). An advanced degree is desirable.
• 10+ years in the pharmaceutical industry with a deep understanding of drug development.
• Prior project management experience with NDA/MAA/Lifecycle submissions and review is required.

Knowledge, Skills and Abilities:

• Expert in project management with advanced expertise using related software and tools (e.g. MS Project, Sharepoint, Veeva, etc).
• Demonstrated experience in leading decision-making within cross-functional teams.
• Excellent organizational and communication skills, both written and verbal.
• Ability to work independently, influence senior stakeholders, set strategic project direction, and manage ambiguity.
• Proactive, collaborative, and solution-oriented with strong organizational discipline.
• Strong interpersonal skills and the ability to lead, mentor, and develop regulatory project managers/other junior staff as needed.

The salary range for this position is $230,000 to $250,000USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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