Associate Director, Regulatory Operations
TP Therapeutics, Inc. (TP) is a clinical-stage structure-based oncology drug design company founded in October 2013 by Dr. J. Jean Cui, the lead inventor of Pfizer’s oncology drug crizotinib and lorlatinib. The TP team is focused on the design and development of novel chemical entities within oncology for established oncogene drivers with high incidence of secondary resistance mutations; newly identified disease-driven targets; and potential targets regulating the tumor microenvironment and tumor immunity. For more information, please visit us at www.tptherapeutics.com.
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%
EEO & Employment Eligibility
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.