Regulatory Affairs Project Lead – NDA Submissions & MDR

Anika Therapeutics; Bedford (MA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

Health savings account

401(k) with company match

Employee stock purchase plan

Paid time off

Stock awards

Job summary

Anika Therapeutics, Bedford, MA, is seeking an Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional regulatory programs for pharma, biotech and medical device products.

You will plan, execute, and coordinate NDA submissions, CMC activities, and regulatory strategies across global teams. The role requires strong project management, NDA and CMC knowledge, and the ability to influence without direct authority.

Qualifications

• Bachelor’s degree in a scientific field or related discipline.
• 5+ years in regulatory affairs, regulatory operations, or regulatory project management in pharma/biotech/medical device.
• Knowledge of NDA submission requirements and CMC regulatory processes.
• Experience coordinating cross-functional regulatory programs with multiple stakeholders.
• Familiarity with medical device regulatory requirements and quality systems.
• Proficiency with project management tools and MS Office.

Responsibilities

• Lead cross-functional regulatory project teams to meet milestones.
• Develop, maintain, and communicate integrated regulatory plans and timelines.
• Coordinate FDA NDA submissions, amendments, supplements, and annual reports.
• Manage CMC-related regulatory deliverables across manufacturing, analytical, quality, and regulatory teams.
• Support regulatory submission planning, content development, and review cycles.
• Monitor risks, dependencies, and mitigation strategies; escalate issues to leadership.
• Drive EU MDR implementation projects including gap assessments and documentation planning.
• Lead governance meetings and report status to management.

Skills

Regulatory project mgmt

Cross-functional leadership

FDA NDA knowledge

CMC knowledge

Stakeholder management

Project planning

MS Office

Education

Bachelor’s degree in a scientific discipline, engineering, pharmacy, life sciences, or related field

Tools

MS Project

Microsoft Office

Job description

Anika Therapeutics, Bedford, MA, is seeking an Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional regulatory programs for pharma, biotech and medical device products.

You will plan, execute, and coordinate NDA submissions, CMC activities, and regulatory strategies across global teams. The role requires strong project management, NDA and CMC knowledge, and the ability to influence without direct authority.