Associate Director, Regulatory Project Management

POSITION SUMMARY

The Associate Director, Regulatory Project Management is responsible for project management activities 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 and manage timelines/dashboards to support regulatory filings through licensure and beyond.

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 and 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.
• 8+ years in the pharmaceutical industry with a fluent understanding of drug development.
• Prior project management experience with NDA/MAA/Lifecycle submissions and review is required.

Knowledge, Skills and Abilities:

• Highly skilled in project management with experience 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 stakeholders, and manage ambiguity.
• Proactive, collaborative, and solution-oriented approach with strong organizational discipline.