Regulatory Systems and Process Optimisation Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Systems and Process Optimisation Manager based in the United States.

Join a global life sciences environment where technology, regulatory expertise, and process innovation come together to improve how critical business decisions are made. In this role, you will lead the strategic evolution of regulatory systems and capabilities, helping transform complex processes into scalable, compliant, and data-driven solutions. You will work across Regulatory Affairs, technology teams, and business stakeholders to optimize platforms, enable automation, and unlock new opportunities through AI-driven improvements. This position offers the opportunity to shape enterprise-level transformation initiatives, influence future regulatory operations, and drive measurable value within a highly collaborative and innovative organization.

Accountabilities: Lead the strategic evolution and optimization of regulatory systems, processes, and data capabilities, ensuring scalable, compliant, and user-friendly solutions.

Define and execute roadmaps for regulatory technology initiatives, aligning priorities with business objectives, regulatory requirements, and digital transformation strategies.

Drive improvements across regulatory platforms, including Veeva Vault RIM and connected systems, ensuring effective data flows, integrations, and process alignment.

Lead business-side integration mapping activities by collaborating with business experts, IT teams, technical stakeholders, and system owners to define requirements and optimize connected capabilities.

Identify opportunities to simplify, automate, and harmonize regulatory processes while maintaining compliance and improving operational efficiency.

Manage the progression of system, process, and data changes through delivery frameworks, coordinating requirements gathering, validation, testing, user acceptance testing (UAT), and implementation readiness.

Support adoption initiatives by developing training approaches, change management plans, and communication strategies for new regulatory capabilities.

Monitor industry trends, regulatory changes, and emerging technologies to proactively shape future capabilities and maintain operational readiness.

Promote continuous improvement by leveraging customer insights, data quality indicators, automation opportunities, and AI-enabled solutions to enhance regulatory operations.

Requirements

5+ years of experience in regulatory affairs, regulatory operations, regulatory systems, quality, data management, process optimization, or digital transformation within pharmaceutical, consumer health, or life sciences environments.

Strong hands-on experience with Veeva Vault RIM, including regulatory data, master data, metadata, document management, workflows, submissions, lifecycles, and system integration capabilities.

Proven experience translating business needs into system enhancements, process improvements, and scalable digital solutions.

Experience leading cross-functional transformation initiatives involving regulatory processes, data, systems, and measurable business outcomes.

Familiarity with Azure DevOps or similar delivery models, including requirements management, solution validation, testing, implementation readiness, and compliant change processes.

Experience with automation, AI-enabled process optimization, or data improvement initiatives is highly desirable.

Strong understanding of regulatory processes, submissions, compliance requirements, GxP environments, inspection readiness, and validated system change control.

Demonstrated ability to engage senior stakeholders, IT partners, external providers, and global teams within complex matrix organizations.

Strong analytical, problem-solving, communication, facilitation, and technical writing skills, with the ability to translate business needs into clear requirements.

Experience with IDMP, XEVMPD, regulatory data standards, AI-enabled improvements, or regulatory technology innovation is considered an advantage.

Fluent written and spoken English with the ability to influence stakeholders and lead strategic discussions.

Benefits

Competitive compensation package based on experience, qualifications, and role scope.

Eligibility for variable compensation components, including annual or performance-based incentives.

Hybrid work model offering flexibility between remote and office-based work.

Comprehensive healthcare and supplementary medical services.

Flexible benefits supporting employee well-being and personal needs.

Life, accident, and disability insurance coverage.

Employer-supported pension plan.

Home office allowance to support flexible working arrangements.

Additional paid leave opportunities depending on employment conditions.

Opportunity to work on global regulatory transformation initiatives involving advanced technologies, automation, and AI.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1