The Opportunity:

• Lead and be accountable for global regulatory submission execution across all application types, supporting increasing submission volume, portfolio expansion, and organizational growth.
• Provide strategic and operational leadership within Regulatory Operations, contributing to functional direction, capability planning, and continuous improvement while maintaining strong executional accountability.
• Translate regulatory strategies into executable submission plans, timelines, resource requirements, and operational approaches.
• Provide oversight for the planning, preparation, publishing, submission, and archiving of high-quality, compliant global regulatory dossiers.
• Lead, mentor, and develop a submissions-focused team, fostering accountability, collaboration, operational excellence, and continuous improvement.
• Oversee external publishing vendors to ensure timely, compliant, high-quality execution and effective use of external resources.
• Define, own, and maintain submission-related standard operating procedures (SOPs), work instructions, job aids, standards, policies, and best practices to drive consistent execution across programs and regions.
• Drive continuous improvement of submission processes to reduce cycle times, increase predictability, improve quality, and support organizational scale.
• Ensure submission processes and practices align with Quality systems, regulatory requirements, and inspection-readiness expectations.
• Partner closely with Regulatory Affairs, Medical Writing, Quality, Clinical Operations, and other cross-functional stakeholders to establish clear roles, effective handoffs, and coordinated execution across the submission lifecycle.
• Provide operational guidance and training to cross-functional contributors involved in regulatory submissions.
• Communicate complex submission issues and risks clearly and proactively, developing practical solutions that balance compliance, business needs, and the demands of a growing portfolio.
• Advance cross-functional initiatives that improve Regulatory effectiveness and support broader departmental objectives.
• Partner with the Regulatory Systems lead to define business requirements, provide operational input, and ensure regulatory systems and processes effectively support submission execution.

Required Skills, Experience and Education:

• Bachelor's degree in a life science, or related field with 12+ years of experience in the biotechnology, pharmaceutical, or medical device industry.
• Seasoned people manager with demonstrated experience leading and developing high-performing teams.
• Proven leadership in developing and executing Regulatory Operations strategies within global biotechnology or biopharmaceutical organizations.
• Deep expertise in global submission planning and execution, electronic Common Technical Document (eCTD) standards, regulatory frameworks, and Health Authority requirements.
• Demonstrated ability to contribute to operational strategy while maintaining strong accountability for submission execution, quality, and process excellence.
• Strong understanding of regulatory systems from a submissions operations, business-process, and end-user perspective.
• Experience leading process improvement initiatives within a regulated, compliance-focused environment.
• Strong project and operational management skills, with the ability to manage multiple priorities and deliver results in a dynamic environment.
• Clear and persuasive communicator with the ability to translate complex operational issues for technical, cross-functional, and senior stakeholders.
• Effective collaborator with demonstrated ability to influence and align cross-functional teams.
• Strategic thinker with a practical problem-solving mindset and ability to balance immediate execution needs with longer-term organizational scalability.
• Proficiency with DocuBridge and Veeva Regulatory Information Management (RIM).

Preferred Skills:

• Hands-on regulatory publishing experience with the technical capability to provide publishing support when needed.
• Experience using Smartsheet for submission planning, project tracking, and collaboration.
• Eperience supporting or managing a global regulatory portfolio.

#LI-JC1 #LI-Hybrid

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Base Pay Salary Range

$211,000-$264,000 USD

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