A growing biotech is seeking a Director of Regulatory Operations to play a pivotal role in overseeing the regulatory strategy and operations for the company's global submissions and systems projects in a dynamic and rapidly evolving environment. This company is focused on developing innovative therapies for rare and undeserved diseases, with a strong emphasis on using cutting-edge science to target key biological pathways for genetic conditions. This role requires strong leadership in regulatory operations, ensuring efficient submission processes and compliance while fostering collaboration across cross-functional teams.
Responsibilities
- Provide regulatory operations expertise and leadership to cross-functional teams supporting the pipeline, train and lead regulatory operations personnel reporting into this role.
- Lead the development, refinement, and implementation of internal processes, procedures, work instructions, and training programs for submission production and operational support activities. As needed, train colleagues and project teams.
- Oversee full implementation, maintenance & optimization of a Regulatory Information Management (RIM) system.
- Provide RIM system leadership by overseeing the development of RIM projects based on current and future business needs, optimizing the use of system attributes.
- Oversee and manage all global regulatory submissions, systems-related projects, and submission compliance.
- Oversee management of external publishing vendors.
- Ensure proper maintenance of regulatory submissions filing, Health Authority correspondence logs, and archival of previous regulatory submissions.
- Oversee the build of submission binders & content plans for future regulatory submissions globally.
- Stay current with regulatory requirements and industry best practices.
- Prepare and present regulatory reports, metrics, and dashboards.
- Lead budgeting and forecasting activities for the Global Reg Ops function, including managing vendors.
Requirements
- Bachelor's Degree in life sciences or a related field
- 8+ years of Regulatory Operations experience in pharma/biotech
- NDA/MAA filing experience.
- Expert knowledge of regulatory submission publishing standards and procedures, including computer word processing and electronic document management systems.
- Understanding of drug development and business processes.
- Knowledge and experience of eCTD submissions.
- Knowledge of FDA, EMA, and ICH guidelines.
- Proven internal and external leadership with the ability to work cross-functionally and globally.
- Ability to work independently and successfully in a matrix environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and balance competing priorities effectively.
- Extensive knowledge in the implementation of GxP Systems (e.g., Document Management Systems) and formatting solutions (e.g., authoring templates).
- Comfortable in a small company environment that is fast-paced, challenging, and take a hands-on approach to get results.
