Regulatory Affairs Senior Project Lead - NDA Submissions

Anika; Bedford (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

401(k) plan with company match

Stock purchase plan

Paid time off

Long-term incentives

Job summary

Anika is seeking an experienced Regulatory Affairs Project Manager/Sr. Manager in the United States to lead cross-functional regulatory programs across pharma, biotech, and medical device products.

The role focuses on regulatory planning, submission readiness, and program coordination, partnering with Regulatory Affairs, Quality, Clinical, CMC, Manufacturing, R&D, and Commercial teams. The ideal candidate has deep NDA knowledge, CMC expertise, and strong project-management skills to ensure

Qualifications

• Bachelor's degree in a scientific discipline, engineering, pharmacy, life sciences, or related field.
• 5+ years of experience in regulatory affairs, regulatory operations, regulatory project management, or related function in pharma/biotech/medical device.
• Demonstrated knowledge of FDA NDA submission requirements and processes.
• Strong understanding of CMC development, documentation, and regulatory requirements.
• Experience leading complex, cross-functional regulatory programs with multiple stakeholders.

Responsibilities

• Lead cross-functional regulatory project teams to ensure timely planning, execution, and delivery of regulatory milestones.
• Develop and communicate integrated regulatory project plans, timelines, risks, dependencies, and resource needs.
• Coordinate activities supporting FDA NDA submissions, amendments, supplements, annual reports, and other regulatory filings.
• Manage regulatory deliverables for CMC development programs with manufacturing, analytical, quality, and regulatory teams.
• Elevate risks and issues to leadership with mitigation strategies and status updates.
• Drive collaboration across Regulatory Affairs, Quality, Clinical, R&D, Operations and external partners.
• Lead project governance meetings and communicate status to management and executives.

Skills

Regulatory PM

Cross-functional leadership

Project planning

Stakeholder mgmt

Regulatory strategy

Education

Bachelor's degree in science/engineering

Tools

Microsoft Office

PM tools

Job description

Anika is seeking an experienced Regulatory Affairs Project Manager/Sr. Manager in the United States to lead cross-functional regulatory programs across pharma, biotech, and medical device products.

The role focuses on regulatory planning, submission readiness, and program coordination, partnering with Regulatory Affairs, Quality, Clinical, CMC, Manufacturing, R&D, and Commercial teams. The ideal candidate has deep NDA knowledge, CMC expertise, and strong project-management skills to ensure