Director, Regulatory Operations and Submission Management
The Director, Regulatory Operations and Submissions Management will support regulatory objectives for the company’s development and marketed products including coordination, preparation, and management of global submissions, compliance with submissions requirements clinical trial and marketing applications, and business administration for electronic submission tools and document managements systems.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Supervise, mentor, train and develop staff involved in regulatory submissions.
- Collaborate with Drug Development contributing departments on planning global submissions.
- Manage 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.
- 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.
- Manage team to provide expertise on requirements for regulatory submissions, health authority briefing documents, and response documents.
- 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.
- Other responsibilities as needed.
- Bachelors in scientific discipline preferred.
- 10+ years of pharmaceutical industry experience with at least 8 years regulatory submissions experience.
- Strong experience using eCTD tools and EDMS applications.
- Strong communication skills with demonstrated ability to present and articulate requirements.
- Experience in working on teams. Ability to work through others to attain goals.
- 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 attention to detail, strong project management skills and ability to work in a fast-paced environment.
- Ability to apply knowledge to new situations.
- Minimal travel is to be expected, approximately 10%.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.