Vice President, Regulatory Operations & Freedom to Operate

Job Description

About the Role

Operating within a highly regulated, innovation-driven environment, our organization delivers complex products and platforms that intersect science, technology, and global regulatory frameworks. Regulatory Operations and Freedom to Operate are not support functions; they are strategic enablers of growth, innovation, and market access.

The Vice President, Regulatory Operations & Freedom to Operate is a senior executive role responsible for shaping global regulatory strategy, ensuring operational excellence in regulatory execution, and protecting the organization’s ability to innovate, launch, and scale without unnecessary constraints. This leader will oversee regulatory operations, compliance infrastructure, IP-aligned regulatory positioning, and cross-functional coordination to support enterprise expansion.

This role is designed for a seasoned regulatory executive with deep experience navigating complex regulatory landscapes while balancing speed, innovation, risk management, and commercial objectives.

Essential Duties and Responsibilities

• Lead global regulatory operations strategy across product development, commercialization, and lifecycle management.

• Establish and maintain Freedom to Operate (FTO) frameworks in collaboration with Legal, IP, R&D, and Product teams.

• Oversee regulatory submissions, renewals, variations, and approvals across domestic and international markets.

• Design scalable regulatory operating models that support innovation pipelines and accelerated product launches.

• Partner with R&D and Product leaders to ensure regulatory pathways align with technical and commercial strategies.

• Monitor evolving regulatory requirements and proactively assess the impact on the pipeline, platforms, and market access.

• Guide regulatory risk assessments, mitigation strategies, and governance processes at the enterprise level.

• Represent regulatory perspectives in executive planning, portfolio prioritization, and investment decisions.

• Build and lead high-performing regulatory operations teams and external regulatory partners.

• Ensure inspection readiness, audit preparedness, and sustained compliance excellence.

Job Qualifications and Requirements

• 15+ years of experience in regulatory affairs or regulatory operations within life sciences, biotechnology, medical devices, or similarly regulated industries.

• Demonstrated executive leadership experience managing global regulatory strategies and operations.

• Strong expertise in Freedom to Operate concepts, regulatory-IP alignment, and innovation enablement.

• Proven success navigating FDA, EMA, and other global regulatory authorities.

• Deep understanding of regulatory submission frameworks, lifecycle management, and compliance systems.

• Bachelor’s degree required; advanced degree in science, engineering, regulatory affairs, or law preferred.

• Exceptional ability to operate at the executive level with Board, legal, and enterprise leadership.

Personal Capabilities and Qualifications

• Strategic, forward-thinking leader with strong risk-based decision-making skills.

• Highly analytical with the ability to balance regulatory rigor and business agility.

• Clear, confident communicator with strong executive presence.

• Comfortable leading in complex, ambiguous, and high-stakes environments.

• Collaborative mindset with a proven ability to influence across technical, legal, and commercial teams.

• Strong ethical foundation and commitment to regulatory integrity.

Strategic Support

• Serve as a trusted advisor to the Chief Legal Officer, Chief Scientific Officer, and Executive Leadership Team.

• Support enterprise strategy through regulatory intelligence, market-entry planning, and innovation enablement.

• Partner with Legal and IP teams to align regulatory strategy with intellectual property and competitive positioning.

• Provide executive insight on regulatory risk, global expansion, and long-term compliance sustainability.

• Influence enterprise decisions related to portfolio prioritization, platform expansion, and product innovation.

Working Conditions

• Remote executive role with periodic travel for regulatory engagements, leadership meetings, and strategic planning sessions.

• Collaboration across global time zones with internal teams, regulators, and external partners.

• High-visibility role with accountability for regulatory outcomes and enterprise-level risk management.

• Fast-paced environment requiring resilience, precision, and sound judgment.

Job Function

• Lead regulatory operations and Freedom to Operate strategy at the enterprise level.

• Enable compliant, efficient, and scalable product development and commercialization.

• Protect innovation pipelines while supporting growth and market access.

• Drive regulatory excellence through strong governance, execution, and leadership.

Compensation & Benefits

• Base Salary: $344,000 – $400,000

• Executive annual bonus program

• Long-term incentive plans (equity, LTIP, or performance-based awards)

• Comprehensive executive benefits, including:

  • Health, dental, vision, and wellness programs

  • Retirement and savings plans

  • Paid executive time off

  • Leadership development and executive coaching

  • Mental health and wellbeing resources

  • Remote work and travel support

Why Join Us

• Play a pivotal role in enabling innovation within a highly regulated global environment.

• Influence enterprise strategy at the highest levels of leadership.

• Lead regulatory operations that directly impact growth, market access, and competitive advantage.

• Work within a modern, forward-looking organization committed to scientific and technological advancement.

• Clear pathway to broader executive leadership roles, including Chief Regulatory Officer or Chief Compliance Officer.