Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients.
The company’s pipeline of drug candidates also includes TPX-0022, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer.
Turning Point’s next-generation kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.
Turning Point Therapeutics is seeking a Senior Manager, Regulatory Operations. The Regulatory Operations Senior Manager will be responsible for the daily operational activities for global regulatory submissions and archives in accordance with health authority requirements and company standards. Provide department support of the Regulatory Information Management System (VEEVA RIM). Reports to Director, Regulatory Affairs.
DUTIES AND RESPONSIBILITIES:
- Manage and perform daily operational activities for global regulatory submissions (project management, submission scheduling, formatting regulatory documents, publishing, QC, archive and submission of dossiers to regulatory health authorities)
- Coordinate submission activities with third party vendors
- Collaborate with interdisciplinary teams, and Regulatory Affairs in the management of submission components and tracking of deliverables
- Ensure consistency, completeness, and adherence to Global Health Authority guidelines, internal Company work instructions and SOPs
- Manage and prioritize multiple tasks in a fast-paced environment while keeping with submission timelines
- Evaluate, author and review SOPs, Guidelines and Work Instructions to ensure regulatory documents, submissions, and systems are well-controlled and comply with applicable regulations
- Operate as Subject Matter Expert in dossier types, eCTD organization and/or processes with responsibility for mentoring team members
- Represent Regulatory Operations in interdisciplinary meetings
- Stay current with new electronic submission and regulatory documentation practices issued from global health authorities
- Assumes other relevant assignments as needed
- Maintain tracking documents as well as publishing and submission calendars
- Understand the legal and compliance environment and drive collaborations with Quality Assurance, Legal and other Compliance team members.
DESIRED SKILLS AND EXPERIENCE:
- Bachelor’s degree with 8 years of experience in the pharmaceutical industry, 6+ years in regulatory operations, preferred; or equivalent combination of education and industry experience.
- Advanced technical experience with formatting in Microsoft Word and Adobe Acrobat. Must have experience with document rendering to PDF, bookmarking and hyperlinking to make documents eCTD ready for global submissions.
- Experience with creating/maintaining templates and electronic submission building tools such as Toolbox, eCTD validation and viewers
- Experience using electronic Regulatory Information Management system (VEEVA RIM)
- Requires knowledge of applicable Regulatory Agency regulations, guidelines, and specification (FDA, HC, EMA, ICH, etc)
- Works independently, is able to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under stringent timelines
- Ability to independently problem solve and offer solutions to functional leaders and collaborators
- Strong verbal and written communications skills in a business setting