San Diego, CA
Associate Director, Regulatory Operations
General Job Description:
The Regulatory Operations Associate Director will be responsible for overseeing operational aspects of all regulatory submissions, ensuring that the submissions are of highest quality, delivered on-time, and within established budget. The position will also support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners. Emphasis will be on proper planning, management, and superior execution on all aspects of regulatory affairs operations.
Under direction from, and in collaboration with the Vice President, Regulatory Affairs, the Regulatory Operations Associate Director will:
Collaborate with teams to plan, create and submit original US INDs and amendments, original US NDAs, amendments and supplements, EU MAAs, Canadian NDS’, amendments and variations in eCTD format and ex-US clinical trial applications in electronic or paper formats, as required (formatting, publishing, submitting, life-cycling, and archiving sequences).
Oversee technical aspects for submissions (eg, eCTD document granularity, utilization of content templates, document formatting, eCTD application location and lifecycle assignment, publishing, QC, validation, and transmission to regulatory health authorities).
Serve as system owner for regulatory information tools and systems (eg, eCTD publishing tools, electronic document management system (EDMS), library system and electronic templates).
Ensure that regulatory information tools and systems are implemented, validated, and maintained in accordance with company SOPs and applicable regulations.
Maintain expert knowledge of electronic submission and computerized system validation standards.
Identify potential risks to submission plans and propose risk mitigation strategies.
Ensure tracking and archiving of regulatory communications and submissions.
Support budgeting and forecasting for function and Regulatory Affairs department.
Provide recommendations on resource needs for regulatory operations and records management activities including the need for outsourcing (e.g., eCTD vendor, SPL vendor).
Represent Regulatory Operations in project teams to support submission planning and ensure coordination of system development activities.
Manage selection, implementation, validation (as applicable) and maintenance of IT tools for regulatory team.
5-7 years’ experience working in a Regulatory Operations environment with demonstrated ability to present and articulate requirements
Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing software
Experience managing EDMS, regulatory publishing systems, and tracking databases
Advanced user skills using MS Word, MS SharePoint, Adobe Acrobat Professional, eCTD content templates and experience with MS Excel, MS PowerPoint, and MS Project or Smartsheets
Familiarity with interpretation of applicable FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications
Demonstrated experience and a clear understanding of submission content and format requirements
The ability to multitask, prioritize, and work under pressure in adhering to deadlines
Solid experience administering and maintaining Regulatory document authoring templates
Strong oral and written communication and interpersonal skills
Strong project management and organizational skills
Ability to apply knowledge to new situations.
Minimal travel is to be expected, approximately 10%
Application Information & Contact (How to Apply)
To apply, please submit your resume to firstname.lastname@example.org