Associate Director/Director, Program Management (Regulatory Submissions)

Responsibilities

• Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements
• Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)
• Oversee project team delivery of the marketing authorization applications
• Develop and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, and resource requirements
• Monitor project progress and provide regular updates to Program Leader and other stakeholders, ensuring clear communication and transparency
• Own program reports / dashboards to executive and other governance teams
• Establish best practices and SOPs as needed for marketing application related submission processes

Requirements

• 10+ years of relevant experience of project management experience in the biotech, pharmaceutical, or life sciences industry
• Strong understanding of drug development and how biotech functions integrate
• Experience in managing cross-functional teams and complex projects in late-stage drug development, with experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred
• Demonstrated project management and interpersonal skills
• Excellent problem-solving and organizational skills, attention to detail, and analytical skills
• Able to manage multiple priorities in a fast-paced, dynamic environment
• Comfortable navigating ambiguity and driving clarity
• Responds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment
• Proven record of collaboration and excellent communication
• Proficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)

Qualifications

• Bachelor’s degree in science, engineering, or a related field; advanced degree preferred
• Advanced degree 5+ years of experience for Associate Director
• Advanced degree 8+ years of experience for Director

Benefits

Comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown.

Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.