Director, Regulatory Operations

W2 Contract

Pay Rate: $100 - $110 per hour

Location: Redwood City, CA - Remote Role

Job Summary:

The Director of Regulatory Operations will lead and be accountable for global regulatory submissions execution, submission-related policies, and end-to-end regulatory processes that support growth and increased portfolio complexity. This position offers the opportunity to strengthen and mature submissions operations through clear process ownership, procedural rigor, and operational excellence. Reporting to the Head of Regulatory Operations, this role serves as a strategic leader within Regulatory Operations, contributing to functional direction, capability planning, and continuous improvement while maintaining strong executional accountability. Success in this role requires the ability to execute while building, work effectively in a dynamic and highly collaborative environment, and remain flexible and adaptive as priorities evolve. 

Duties and Responsibilities:

• Provide operational leadership and accountability for global regulatory submissions across all application types, with strategic input to support increasing submission volume, portfolio expansion, and organizational growth. 
• Advance cross-functional initiatives that enhance the department's effectiveness and support broader Regulatory objectives. 
• Translate regulatory strategies into executable submission plans, timelines, and resource models. 
• Provide oversight for teams responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers. 
• Lead and mentor a submissions-focused team and oversee external vendors to ensure timely, compliant, and high-quality regulatory publishing. 
• Communicate complex issues clearly, providing solutions that balance compliance with the demands of scale. 
• Drive the development, optimization, and implementation of procedures, training, and documentation to support compliant and efficient submission operations. 
• Define, own, and maintain regulatory submissions–related SOPs, work instructions, job aids, standards, policies, and best practices to ensure consistent execution across programs and regions. 
• Drive continuous improvement of submission processes to reduce cycle times, increase predictability, and improve quality. 
• Ensure alignment of submission processes with Quality systems and inspection-readiness expectations. 
• Partner closely with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners to ensure seamless handoffs and role clarity across the submission lifecycle. 
• Provide clear operational guidance and training to cross-functional contributors involved in submissions. 
• Partner with the Regulatory Systems lead by providing business requirements, operational input, and process alignment to ensure systems effectively support submissions execution, without serving as system owner or administrator. 

Requirements and Qualifications:

• Provide operational leadership and accountability for global regulatory submissions across all application types, with strategic input to support increasing submission volume, portfolio expansion, and organizational growth.
• Advance cross-functional initiatives that enhance the department's effectiveness and support broader Regulatory objectives.
• Translate regulatory strategies into executable submission plans, timelines, and resource models.
• Provide oversight for teams responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers.
• Lead and mentor a submissions-focused team and oversee external vendors to ensure timely, compliant, and high-quality regulatory publishing.
• Communicate complex issues clearly, providing solutions that balance compliance with the demands of scale.
• Drive the development, optimization, and implementation of procedures, training, and documentation to support compliant and efficient submission operations.
• Define, own, and maintain regulatory submissions–related SOPs, work instructions, job aids, standards, policies, and best practices to ensure consistent execution across programs and regions.
• Drive continuous improvement of submission processes to reduce cycle times, increase predictability, and improve quality.
• Ensure alignment of submission processes with Quality systems and inspection-readiness expectations.
• Partner closely with Medical Writing, Regulatory Affairs, Quality, Clinical Operations, and external partners to ensure seamless handoffs and role clarity across the submission lifecycle.
• Provide clear operational guidance and training to cross-functional contributors involved in submissions.
• Partner with the Regulatory Systems lead by providing business requirements, operational input, and process alignment to ensure systems effectively support submissions execution, without serving as system owner or administrator.

Preferred Qualifications:

• Seasoned people manager.
• Adept in regulatory publishing; capable of serving as a backup publisher.
• Proficient in Sartsheet for project tracking and collaboration.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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