Associate Director, Regulatory Operations

The Opportunity:

The Associate Director, Regulatory Operations will serve as a key publishing lead within the Regulatory Operations function, responsible for managing and executing regulatory submission activities to support the company’s growing pipeline and portfolio. This individual will ensure timely, accurate, and compliant submissions to the FDA and other global Health Authorities while contributing to the effective management of regulatory information, systems, and processes that enable operational efficiency and scalability.

This role is an individual contributor with leadership responsibilities, partnering cross-functionally with clinical, quality, CMC, nonclinical, and regulatory strategy teams to ensure seamless document management, publishing, and submission execution. The Associate Director also plays a key role in maintaining the integrity of regulatory information and ensuring compliance with global health authority requirements in a dynamic, fast-paced environment.

Regulatory Publishing & Submission Management

• Oversee the planning, preparation, publishing, submission, and archiving of regulatory dossiers in eCTD format for multiple FDA applications and global submissions.

• Manage submission production and quality control (QC) processes, ensuring compliance with global regulatory requirements and internal standards.

• Provide technical expertise in eCTD publishing tools and platforms (e.g., Veeva Vault RIM) to enable efficient and compliant submission execution.

• Proactively manage publishing timelines from request through archive, anticipating potential issues, escalating risks early, and collaborating with cross-functional teams to adapt plans as needed.

Systems, Tools & Process Optimization

• Support the implementation, optimization, and maintenance of regulatory systems, tools, and technologies to improve submission efficiency and scalability.

• Partner with cross-functional stakeholders to ensure regulatory systems and workflows are well-documented, scalable, and aligned with business needs.

• Drive the development and continuous improvement of SOPs, templates, style guides, and document standards to support compliance and operational efficiency.

• Stay informed on emerging tools, technologies, and industry best practices, identifying opportunities to enhance submission operations and supporting the evaluation and adoption of innovative solutions where appropriate.

Cross-Functional Leadership & Vendor Oversight

• Collaborate with internal stakeholders across clinical, CMC, quality, nonclinical, and regulatory strategy teams to coordinate the creation, review, and approval of regulatory submission documents.

• Manage relationships with publishing vendors and consultants, ensuring appropriate resource allocation and adherence to quality and delivery expectations.

• Provide training and guidance to internal teams on publishing procedures, tools, and best practices to ensure submission readiness.

Strategic Contribution & Compliance

• Communicate complex regulatory and operational issues clearly, providing solutions that balance compliance with the demands of growth and scale.

• Conduct gap analyses of regulatory operations policies, procedures, and SOPs, driving initiatives to enhance departmental efficiency and compliance.

• Maintain current knowledge of regulatory requirements, evolving eCTD guidance, and the broader regulatory operations landscape, providing interpretation and guidance to internal stakeholders.

Required Skills, Experience and Education:

• Bachelor’s degree in a life science, technical, or related field with 8+ years of Regulatory Operations and publishing experience in the biopharmaceutical industry; advanced degree preferred.

• Expert-level proficiency in Microsoft Word, Adobe Acrobat Professional, Toolbox, and StartingPoint.

• Thorough understanding of eCTD publishing standards, submission formatting, transmission, and archiving regulations and guidelines.

• Experience preparing and submitting regulatory dossiers to multiple global Health Authorities; oncology experience is a plus.

• Demonstrated ability to manage and prioritize multiple FDA applications and submissions with overlapping deadlines while maintaining accuracy and compliance.

• Ability to anticipate risks and proactively identify solutions to potential publishing and submission challenges.

• Strong organizational skills with high attention to detail and the ability to work independently in a dynamic, fast-paced environment.

• Proven success collaborating with cross-functional teams and external vendors to deliver high-quality, compliant submissions.

• Excellent interpersonal and communication (written and verbal) skills; able to work effectively across multiple groups, maintaining professionalism, diplomacy, and a positive approach.

Preferred Skills:

• Some experience with people management, such as mentoring, training, or overseeing vendors and consultants.

• Proficiency with Veeva Vault RIM or similar regulatory information management systems.

• Experience using Smartsheet or equivalent project management tools. 

  #LI-Hybrid  #LI-SH1