Director, Program Management – Regulatory Submissions

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Collaborate with teams in clinical, regulatory, non-clinical, and technical operations.

• Lead both regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings.

• Oversee project plans from initiation through to completion, ensuring timely delivery, adherence to scope, and budget compliance.

• Identify potential risks and implement effective solutions to mitigate them.

• Spearhead the execution of submission strategies that align with corporate goals and regulatory standards.

• Lead and manage meetings and workstreams for cross-functional submission teams across Regulatory, Clinical, Quality, CMC, and Medical Writing.

• Supervise the project team's delivery of marketing authorization applications.

• Develop and take ownership of integrated marketing authorization plans that outline goals, deliverables, timelines, and resources.

• Monitor project progress and provide regular updates to the Program Leader and relevant stakeholders.

• Manage program reports and dashboards for executive and governance teams.

• Establish best practices and standard operating procedures for marketing application submission processes.

⛳️ Requirements

• Over 10 years of relevant project management experience within the biotech, pharmaceutical, or life sciences sectors.

• Strong understanding of drug development and the integration of biotech functions.

• Experience in managing cross-functional teams and complex projects in late-stage drug development.

• Preferred experience in managing global marketing authorization submissions (NDA, BLA, MAA).

• Demonstrated project management capabilities and strong interpersonal skills.

• Excellent problem-solving, organizational, attention-to-detail, and analytical competencies.

• Ability to handle multiple priorities in a fast-paced and dynamic environment.

• Comfortable navigating ambiguity and providing clear direction.

• Ability to remain composed, resilient, and open-minded in the face of change.

• Proven track record of collaboration and outstanding communication skills.

• Proficient in project management tools including Smartsheet, MS Project, Excel, think-cell, and OnePager.

• Bachelor’s degree in science, engineering, or a related field; advanced degree is preferred.

• Employment eligibility verification through E-Verify.

🏝️ Benefits

• Comprehensive health coverage.

• Flexible time off.

• Paid holidays.

• Year-end shutdown.

• Monthly wellness stipend.

• Generous 401(k) matching.

• Tuition reimbursement.

• Commuter benefits.

• Disability and life insurance.

• Annual bonus opportunities.

• Equity grants.