Associate Director – Program Management, Regulatory Submissions

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

📋 Description

• Contribute to and spearhead the implementation of submission strategies that align with corporate goals and regulatory standards.

• Lead and coordinate cross-functional team meetings and workstreams involving Regulatory, Clinical, Quality, CMC, and Medical Writing.

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

• Develop and take ownership of comprehensive integrated marketing authorization plans, outlining goals, deliverables, timelines, and resource needs.

• Track project progress and provide consistent updates to the Program Leader and other stakeholders, ensuring clear communication and transparency.

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

• Establish best practices and standard operating procedures as necessary for submission processes related to marketing applications.

⛳️ Requirements

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

• Strong knowledge of drug development and integration of functions within biotech.

• Experience in leading cross-functional teams and managing complex projects in late-stage drug development, with a preference for those who have overseen global marketing authorization submissions (NDA, BLA, MAA).

• Proven project management and interpersonal skills.

• Exceptional problem-solving and organizational abilities, with a keen attention to detail and analytical skills.

• Capability to juggle multiple priorities in a fast-paced, dynamic environment.

• Comfortable with navigating uncertainty and bringing clarity to ambiguous situations.

• Maintains composure, resilience, and an open mindset when faced with changing priorities and uncertainties in an evolving environment.

• Demonstrated history of collaboration and outstanding communication skills.

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

🏝️ Benefits

• Comprehensive health coverage.

• Flexible time off.

• Paid holidays.

• Year-end shutdown.

• Monthly wellness stipend.

• Generous 401(k) match.

• Tuition reimbursement.

• Commuter benefits.

• Disability and life insurance.

• Annual bonus opportunities.

• Equity grants.