Director, Regulatory Operations
We are seeking an experienced Regulatory Operations professional to establish an internal Regulatory Operations function within our Regulatory Affairs team. This is an exciting opportunity to build a Regulatory operations group from the ground up, establishing systems and processes to support Kymera’s global regulatory submissions. The ideal candidate considers themselves a Regulatory operations expert, is excited and motivated to build or implement new systems and processes from scratch and to contribute equally through both day-to-day publishing and submission operations as well as strategic group leadership. This role will act in partnership with the Head of Regulatory Affairs to build out compliant, flexible, and usable systems to efficiently compose, submit and archive global regulatory submissions.
Kymera Therapeutics is a clinical stage biotechnology company focused on advancing the field of targeted protein degradation (TPD), a transformative new approach to address previously intractable disease targets. Kymera’s Pegasus™ TPD platform harnesses the body’s natural protein recycling machinery to degrade disease-causing proteins, with a focus on undrugged nodes in validated pathways currently inaccessible with conventional therapeutics. Our mission is to discover, develop, and commercialize transformative therapies while leading the evolution of targeted protein degradation. Kymera’s goal is to become a fully integrated biopharmaceutical company with a pipeline of novel medicines, with an initial focus on immune-inflammatory diseases and oncology.
In 2021, we plan to continue to grow and strengthen our organizational capabilities to deliver on the potential of inventing a new class of protein degrader medicines for patients. Kymera is rapidly advancing three programs in clinical studies this year. We are also actively advancing a broad pipeline of preclinical programs across a wide variety of diseases, both internally and in collaboration with our partners Sanofi and Vertex Pharmaceuticals.
- Leads the Regulatory Operations function, ultimately responsible for the timely, complete and compliant electronic submission of global regulatory submissions.
- Coordinates, manages, and oversees all electronic publishing and submission activities for Regulatory Affairs, Clinical, and Preclinical Development.
- Identifies, implements and owns a fit for Kymera RIM system and eCTD submission software suite.
- Establishes and maintains a complete set of templates to support Regulatory Affairs and other functional areas.
- In addition to a close partnership with Regulatory Affairs, works closely with Medical Writing and Clinical Development to ensure high quality clinical and regulatory documents.
- Contributes to defining and implementing standard processes and best practices for the Kymera regulatory group.
- Monitors the development of emerging regulations and guidances related to data and electronic submission standards and advises on impacts to programs or business operations.
- Mentors and manages junior regulatory operations staff.
- Bachelor’s degree in a scientific discipline
- At least 8 years of Regulatory Operations experience in the pharmaceutical industry, preferably with experience in a biotech environment.
- In-depth knowledge and understanding of regulatory operations principles, practices and industry trends for global regulatory submissions.
- Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools.
- Experience implementing or assisting in the implementation of a RIMS sufficient to support the ownership of this responsibility at Kymera.
- Excellent document formatting/troubleshooting skills in MS Word.
- Adobe Acrobat super user.
- Extensive experience in template design and implementation.
- Understanding of CDISC (ADaM, SEND, SDTM)
- Highly organized with a meticulous attention to detail.
- A self-starter motivated to take on new challenges, work outside their areas of comfort and collaborate cross functionally to contribute to the success of Kymera and its programs.
Kymera Therapeutics is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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Job posted: 2021-04-12