Senior Director, Regulatory Operations

This senior leadership role offers the opportunity to shape and oversee global regulatory operations within an innovative, fast-paced life sciences environment. You will lead regulatory submission strategy, publishing, information management, and systems to support product development and regulatory compliance worldwide. Working closely with cross-functional teams, you will ensure submissions meet the highest standards of quality, accuracy, and timeliness. You will also drive the implementation and optimization of regulatory technology platforms, compliant processes, and document management practices. By monitoring evolving regulations and emerging technologies, you will help the organization anticipate change and maintain global regulatory readiness. This role is ideal for an experienced regulatory operations leader who combines strategic thinking, technical expertise, and a commitment to continuous improvement.

• Bachelor's degree in life sciences or a related discipline with at least 12 years of regulatory experience, or a master's degree in a related field with at least 10 years of regulatory experience.

• At least 6 years of experience in a regulatory operations leadership role, including team leadership and the management of complex operational responsibilities.

• Strong working knowledge of global regulatory submission requirements, including electronic Common Technical Document (eCTD), NeeS, and paper-based submissions.

• Experience managing regulatory submission publishing tools, document templates, formatting processes, and electronic submission workflows.

• Familiarity with Veeva Vault for Submissions or comparable regulatory information and document management systems; experience with ISI Toolbox is also valuable.

• Knowledge of applicable U.S. and international regulations, guidelines, and health authority requirements.

• Demonstrated ability to lead cross-functional initiatives, manage external vendors, and coordinate multiple projects simultaneously.

• Experience with regulatory systems implementation, validation, maintenance, and software lifecycle management.

• Strong project planning, organizational, analytical, and problem-solving skills, with exceptional attention to detail.

• Excellent written and verbal communication skills and the ability to build effective working relationships across multidisciplinary teams.

• Ability to work independently with moderate supervision, exercise sound judgment, and manage competing priorities in a dynamic environment.

• A proactive, adaptable, and collaborative approach, with a commitment to integrity, continuous improvement, and data-driven decision-making.