Associate Director, Regulatory Project Management

Description of Role

The Associate Director, Regulatory Project Management provides project management leadership across Global Regulatory Affairs, supporting assigned development programs and portfolio priorities. Serving as the central hub for regulatory projects, the Regulatory Project Manager (RPM) is accountable for regulatory project timelines, ensuring effective planning, tracking, execution, and delivery of submissions to health authorities worldwide.

The RPM partners across the Regulatory function to coordinate deliverables, maintain oversight of submission plans, and ensure regulatory documents are complete, accurate, and submitted on schedule. The role is responsible for maintaining project records and documentation to support compliance, audit readiness, and regulatory transparency. The RPM also provides regular updates to leadership and key stakeholders, communicating project status, risks, challenges, and milestones to ensure alignment and informed decision-making.

Success in this role requires strong organizational, communication, problem-solving, and time management skills, with keen attention to detail and the ability to manage multiple priorities while navigating evolving regulatory requirements and project constraints.

Key Responsibilities

• ·Project Planning and Execution: Develop and maintain integrated project plans for regulatory submissions (e.g., IND, NDA, BLA, MAA) and post-approval activities, ensuring adherence to scope, timelines, budgets, and quality standard
• Cross-Functional Coordination: Act as the primary regulatory contact for timelines from functions including Clinical, Nonclinical, CMC, Quality, and Commercial, fostering collaboration and alignment
• Risk Management: Identify, assess, and mitigate project risks, creating contingency plans to maintain compliance and meet milestones
• Regulatory Communication: Coordinate with Regulatory Strategy Lead to manage interactions with global health authorities, prepare teams for agency meetings, and lead responses to regulatory queries
• Documentation Oversight: Coordinate the authoring, review, and assembly of submission-ready regulatory dossiers, ensuring accuracy and consistency
• Budget and Resource Management: Develop and track project budgets, forecast expenditures, and report financial performance to leadership

Qualifications

Basic Qualifications:

RPMs typically require a blend of regulatory knowledge and project management expertise. Desired skills include:

• Bachelor’s degree in a scientific or related field
• 8+ years of industry based regulatory experience
• Strong understanding of regulatory frameworks and compliance requirements in relevant industries
• Proficiency in project management tools (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC) for planning, tracking, and reporting
• Excellent interpersonal and communication skills to engage stakeholders, facilitate meetings, and drive decision-making
• Communication skills are crucial for interacting with regulatory bodies, internal management, and cross-functional teams, facilitating collaboration and maintaining project alignment
• Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable project tasks
• Attention to detail is important for preparing accurate documentation and maintaining regulatory compliance

Compensation

The annual base salary range for this position is $140,000.00 to $200,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.

In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Associate Director, Regulatory Project Management role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt