VP, Head of Global Regulatory Affairs

The VP, Head of Global Regulatory Affairs provides strategic leadership for the global regulatory function across the company's development and commercial portfolio. This role is accountable for defining and executing global regulatory strategies that enable successful product development, approvals, lifecycle management, and commercialization worldwide. As the senior regulatory leader, the VP serves as the primary interface with global health authorities and a key contributor to enterprise governance and portfolio decision-making. The role also leads the regulatory function’s digital and AI transformation agenda, advancing data-enabled decision-making, regulatory intelligence, automation, and innovative operating models that improve quality, speed, compliance, and enterprise impact.

You will be responsible for:

· Lead the Global Regulatory Affairs organization and establish regulatory strategy aligned with corporate and portfolio objectives.

· Provide strategic regulatory leadership across all stages of development, from early research through commercialization and lifecycle management.

· Oversee global regulatory submissions, approvals, labeling strategies, maintenance activities, and regulatory compliance.

· Serve as the primary regulatory representative with FDA, EMA, PMDA, and other global health authorities, leading critical agency interactions and negotiations.

· Ensure regulatory risks, opportunities, and strategies are effectively integrated into portfolio, investment, and development decisions.

· Partner with R&D, Medical, Commercial, Quality, Manufacturing, and Executive Leadership teams to drive successful global development and registration outcomes.

· Build, develop, and retain a high-performing global regulatory organization while ensuring effective resource allocation and succession planning.

· Lead the digital and AI transformation of Global Regulatory Affairs, including regulatory information management, automation, data governance, advanced analytics, and AI-enabled regulatory intelligence and submission capabilities.

· Partner with Digital, IT, Data Science, Quality, Compliance, and business leaders to ensure responsible adoption of digital tools and AI, with appropriate standards for data quality, privacy, transparency, validation, inspection readiness, and regulatory compliance.

· Represent the company externally through regulatory agencies, industry associations, and key scientific and policy forums.

You will need to have:

· Advanced scientific degree (PhD, PharmD, MD, MS, or equivalent preferred).

· 20+ years of leadership experience in Global Regulatory Affairs within the biopharmaceutical industry.

· Demonstrated success delivering major global approvals, registrations, launches, and lifecycle expansions.

· Deep expertise across rare disease and/or specialty biopharmaceutical portfolios.

· Broad drug development experience spanning early development through commercialization.

· Strong FDA, EMA, PMDA, and global health authority engagement experience.

· Proven track record shaping regulatory strategy at both asset and portfolio levels.

· Demonstrated success leading global regulatory organizations and developing high-performing talent.

· Influential enterprise leader with experience contributing to senior governance and portfolio decision forums.

· Experience sponsoring or leading digital transformation initiatives within Regulatory Affairs, including adoption of regulatory technology platforms, data-driven operating models, automation, and AI-enabled capabilities.

· Extensive experience leading global regulatory submissions and securing approvals across multiple regions.

We would prefer for you to have:

· Experience leading Regulatory Affairs within a global biotechnology or specialty pharmaceutical organization.

· Direct experience in rare disease product development, registration, and commercialization.

· Established relationships and credibility with major global health authorities.

· Experience representing organizations within industry associations and regulatory advocacy groups.

· Record of successful leadership during periods of organizational growth, transformation, or portfolio expansion.

· Experience advancing responsible AI, regulatory intelligence, submission automation, knowledge management, or predictive analytics capabilities in a global regulated environment.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.