Director, Regulatory Operations

17 hours ago Be among the first 25 applicants

Location: Redwood City, CA - Hybrid Role

Job Summary:

The Director of Regulatory Operations will be responsible for developing and scaling a regulatory infrastructure that supports growth and increased portfolio complexity. This position offers the opportunity to build upon an established team and function by implementing the systems, processes, and practices required for long-term scalability and compliance. Reporting to the Senior Director of Regulatory Operations, this individual will support the strategic direction of Regulatory Operations, conduct a thorough analysis of current capabilities, and manage the development and implementation of operational improvements. The role will also provide mentorship to a capable team currently managing health authority submissions and ready for expanded responsibilities. 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:

• Define strategic plans and ensure efficient operational execution with leadership to support increasing submission volume, expansion, and company growth.
• Communicate complex regulatory and operational issues clearly, providing solutions that balance compliance with the demands of scale.
• Advance cross-functional initiatives that enhance the department's strategic impact and operational effectiveness and provide value to the overall positioning of the department
• Translate business needs into scalable, well-documented regulatory systems and process configurations.
• Drive the development, optimization, and implementation of procedures, training, and documentation to support compliant and efficient submission operations.
• Provide oversight for teams responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers.
• Mentor a team towards exceptional performance while coordinating with external vendors to ensure timely, high-quality regulatory publishing.
• Support the system owner and administrator for regulatory technologies (e.g., Veeva Vault RIM); manage implementations, upgrades, and change management activities.
• Champion the adoption of innovative tools and technologies to improve submission operations, regulatory compliance, and organizational scalability cross-functionally.

Requirements and Qualifications:

• Proven leadership in developing and executing regulatory operations strategy within global biotech or biopharma organizations.
• Deep expertise in submission planning, global regulatory frameworks, eCTD standards, and Health Authority requirements.
• Advanced experience managing and configuring regulatory systems, particularly Veeva Vault RIM.
• Strong project management skills, with the ability to oversee multiple priorities and deliver results in a dynamic environment.
• Clear and persuasive communicator across technical and business stakeholders.
• Effective collaborator with the ability to influence and align cross-functional teams.
• Strategic thinker with a practical problem-solving mindset and long-term business orientation.
• Committed to developing high-performing teams and fostering a culture of accountability and continuous improvement.
• Experience leading process improvement and system optimization initiatives in a compliance-focused environment.

Preferred Qualifications:

• Seasoned people manager.
• Adept in regulatory publishing; capable of serving as a backup publisher.
• Proficient in Smartsheet for project tracking and collaboration.
• Extensive hands-on experience with Veeva RIM system management.

Desired Skills and Experience

Regulatory Operations, Veeva Vault RIM, eCTD, Regulatory Submission, Project Management, Smartsheet, Lorenz, DocuBridge, Travel

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

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research and Science

Referrals increase your chances of interviewing at Bayside Solutions by 2x

Get notified about new Director of Operations jobs in San Mateo County, CA .

San Mateo, CA $217,500.00-$353,500.00 2 weeks ago

Senior Operations Manager - Unusual Ventures

Foster City, CA $160,000.00-$200,000.00 3 weeks ago

Director, Global Storage and Distribution

San Mateo, CA $207,000.00-$297,000.00 2 days ago

Chief Operating & Human Resources Officer

San Mateo, CA $150,000.00-$180,000.00 1 week ago

San Mateo, CA $270,890.00-$304,720.00 2 weeks ago

Menlo Park, CA $205,000.00-$230,000.00 4 weeks ago

Senior Manager/Director, Strategy and Operations

Redwood City, CA $174,400.00-$308,400.00 1 week ago

Director, Procurement and Strategic Partnerships

Foster City, CA $219,000.00-$313,000.00 1 week ago

Menlo Park, CA $227,000.00-$296,000.00 2 weeks ago

Director, Workplace Experience - Redwood City

Associate Director/Director, Clinical Operations, Autoimmune

South San Francisco, CA $180,000.00-$240,000.00 9 months ago

South San Francisco, CA $210,000.00-$230,000.00 1 month ago

Sr Director, Business Strategy and Operations

Foster City, CA $243,100.00-$314,600.00 15 hours ago

Associate Director, Supply Chain Operations

Redwood City, CA $185,000.00-$205,000.00 1 week ago

Associate Director / Director, Clinical Operations

Foster City, CA $182,070.00-$235,620.00 7 hours ago

Director, Global External Manufacturing, OSD

Foster City, CA $210,375.00-$272,250.00 1 week ago

South San Francisco, CA $261,000.00-$325,000.00 2 weeks ago

Foster City, CA $210,375.00-$272,250.00 6 days ago

Senior Director, Global Clinical Supply Chain

Foster City, CA $243,100.00-$314,600.00 2 weeks ago

Director, Strategic Partnerships & Client Relationship

Associate Director, Clinical Operations - Oncology (Compound Lead)

South San Francisco, CA $191,000.00-$212,000.00 1 day ago

Director, Business Operations Ecommerce (Sam's Club)

San Bruno, CA $143,000.00-$286,000.00 17 hours ago

Redwood City, CA $265,000.00-$295,000.00 1 week ago

San Mateo, CA $100,000.00-$125,000.00 1 day ago

Brisbane, CA $224,000.00-$308,000.00 1 week ago

Foster City, CA $302,005.00-$390,830.00 1 day ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.