Regulatory Affairs Project Manager/Sr. Manager

Anika Therapeutics•Bedford, MA

8d•$130,000 - $180,000

About The Position

The Regulatory Affairs Project Manager/Sr. Manager leads and coordinates cross-functional regulatory programs supporting pharmaceutical, biotechnology, and medical device products. In this role, you serve as the regulatory project management lead for complex development and commercialization initiatives, with primary responsibility for regulatory planning, execution, submission readiness, and program coordination. The Regulatory Affairs Project Manager/Sr. Manager partners closely with Regulatory Affairs, Quality, Clinical, CMC, Manufacturing, R&D, and Commercial teams to ensure timely execution of regulatory deliverables and alignment with global regulatory and business objectives. This role requires strong project management capabilities, knowledge of pharmaceutical Chemistry, Manufacturing, and Controls (CMC) requirements, experience with FDA New Drug Application (NDA) filings, and working knowledge of medical device regulatory requirements.

Requirements

Bachelor’s degree in a scientific discipline, engineering, pharmacy, life sciences, or a related field.
5+ years of experience in regulatory affairs, regulatory operations, regulatory project management, or a related function within the pharmaceutical, biotechnology, or medical device industry.
Demonstrated knowledge of FDA New Drug Application (NDA) submission requirements and processes.
Strong understanding of pharmaceutical Chemistry, Manufacturing, and Controls (CMC) development, documentation, and regulatory requirements.
Demonstrated experience managing complex, cross-functional regulatory programs involving multiple stakeholders and competing priorities.
Working knowledge of medical device regulatory requirements and quality systems.
Experience developing and managing project plans, timelines, budgets, risks, dependencies, and resource requirements.
Strong organizational, communication, facilitation, and stakeholder management skills.
Demonstrated ability to influence and coordinate cross-functional teams without direct authority.
Proficiency with project management tools and Microsoft Office.

Nice To Haves

PMP certification or equivalent project management certification.
Experience supporting both pharmaceutical and medical device development programs.
Direct experience with NDA, BLA, IND, and/or global regulatory submissions.
Knowledge of EU MDR requirements and experience coordinating implementation activities.
Familiarity with regulatory information management systems and electronic submission platforms.
Experience interacting with FDA, Notified Bodies, and other global regulatory authorities.
Experience supporting combination products, biologics, regenerative medicine, or advanced therapy products.
Demonstrated success leading global regulatory initiatives in a fast-paced biotechnology or medical technology environment.

Responsibilities

Lead cross-functional regulatory project teams to ensure timely planning, execution, and delivery of regulatory milestones.
Develop, maintain, and communicate integrated regulatory project plans, timelines, risks, dependencies, and resource requirements.
Coordinate activities supporting FDA NDA submissions, amendments, supplements, annual reports, and other regulatory filings.
Manage regulatory deliverables associated with CMC development programs, coordinating manufacturing, analytical, quality, and regulatory stakeholders to ensure submission readiness.
Facilitate regulatory submission planning, content development, document collection, review cycles, and milestone tracking.
Monitor project risks and dependencies, develop mitigation strategies, and escalate critical issues to leadership as appropriate.
Support implementation of regulatory strategies throughout product development and lifecycle management activities.
Coordinate EU Medical Device Regulation (EU MDR) implementation projects, including gap assessments, remediation activities, technical documentation planning, and stakeholder engagement.
Drive cross-functional collaboration among Regulatory Affairs, Quality Assurance, Clinical Affairs, R&D, Operations, and external partners.
Lead project governance meetings, document decisions and action items, and communicate project status, risks, and key milestones to management and executive stakeholders.
Develop and maintain project metrics, dashboards, and reporting tools to provide visibility into regulatory program performance and execution.
Support regulatory inspection and audit readiness initiatives, as applicable.
Ensure regulatory project activities comply with applicable FDA, EU, and global regulatory requirements, company procedures, and quality systems.