Senior Regulatory Programs Manager - NDA Submissions

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

Benefits offered by this job

Discretionary bonus

Healthcare benefits

401(k) with company match

Employee stock purchase plan

Job summary

Anika Therapeutics, Inc. seeks a Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional regulatory programs for pharma, biotech, and medical device products.

You will own regulatory planning, execution, submission readiness, and program coordination across global teams. The role requires NDA experience, CMC knowledge, and strong project-management skills to meet timelines while aligning with global regulatory strategies and business goals.

Qualifications

• Bachelor’s degree in scientific field; 5+ years in regulatory affairs or regulatory project management in pharma/biotech/medical device.
• Experience with FDA NDA submissions and CMC knowledge.
• Ability to lead cross-functional teams and manage multiple workstreams.
• Knowledge of EU MDR regulatory requirements.
• Strong communication and stakeholder management skills.

Responsibilities

• Lead cross-functional regulatory project teams to deliver milestones.
• Develop and maintain integrated regulatory plans with timelines, risks, and resources.
• Coordinate FDA NDA submissions, amendments, supplements, and annual reports.
• Ensure submission readiness for CMC development programs with QA/Manufacturing.
• Drive regulatory strategies across product development and lifecycle.
• Oversee EU MDR implementation projects and regulatory interactions.

Skills

Regulatory project management

FDA NDA submissions

Cross-functional leadership

Regulatory strategy

Document management

Communication

Stakeholder management

Budget and timelines

Education

Bachelor’s degree in life sciences or related field

Tools

Microsoft Office

PM software

Job description

Anika Therapeutics, Inc. seeks a Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional regulatory programs for pharma, biotech, and medical device products.

You will own regulatory planning, execution, submission readiness, and program coordination across global teams. The role requires NDA experience, CMC knowledge, and strong project-management skills to meet timelines while aligning with global regulatory strategies and business goals.