Specialist, Regulatory Affairs Operations Publishing
About The Position
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us. Hybrid Employee Value Proposition: At Taiho Oncology, our dedication to science and our patients drives us to work collaboratively across various functions to achieve impactful results. The Regulatory Affairs Operations team creates and manages investigational and marketing applications to health authorities like the FDA and EMA, compiles required data and maintains compliance with evolving regulations and technologies—including AI—to support drug review, approval and market access while protecting public health. This position offers an exciting opportunity to be a part of this dynamic team. Position Summary: Under the direction of regulatory affairs operations management, the incumbent with minimal assistance conducts and supports global regulatory affairs dossier publishing activities. The activities include document and submission preparation and review, communicating with RA staff and other subject matter experts, and updating regulatory submission trackers. The incumbent conducts these regulatory activities to ensure high quality completeness of all dossiers, supporting IND, NDA, MAA, IMPD and CTA submissions. This position will begin to provide in-house publishing in coordination with the publishing vendor resources with dedication, flexibility, and commitment to our goals to deliver highest quality submissions to global health authorities for our products and ultimately our patients.
Requirements
- College degree in scientific field, technology, or related discipline, or equivalent experience is required.
- Advanced skills in eCTD publishing tools (including docuBridge), MS-Office, Adobe Acrobat applications, electronic document management systems (preferably Generis’ CARA), and the ability to learn required systems and processes quickly.
- Assesses the impact of document delays on timing of completion of dossier publishing and communicates these impacts to regulatory affairs management and colleagues.
- Advanced editing and formatting skills requiring use of publishing tools, MS Word, pdf editing tools and templates (including StartingPoint).
- Ability to handle multiple tasks simultaneously with strong attention to detail.
- Minimum of two years hands-on experience and knowledge of IND/NDA/CTA/MAA/eCTD applications and ICH/FDA electronic submission requirements and guidelines.
- Ability to work with strict deadlines, changing requirements and changing priorities.
- Excellent interpersonal, communication, and organizational skills.
- Successful performance in a high-intensity work environment.
- Ability to effectively present information and respond to questions internally and externally.
- Knowledge of PC software, including Microsoft Office products.
- The employee must occasionally lift and/or move up to 20 pounds.
- Specific vision abilities required by this job include close vision and ability to adjust focus.
- The noise level in the work environment is usually quiet.
Responsibilities
- With direction from the manager and regulatory affairs leadership, publishes regulatory affairs dossiers for submission to health authorities.
- Contributes to the development and implementation of dossier publishing processes and procedures to improve efficiency and meet health authority standards.
- Interacts with regulatory affairs and subject matter experts to ensure every published dossier meets health authority and ICH standards.
- Effective communication with regulatory colleagues and subject matter experts.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
