Regulatory Affairs Manager
About The Position
We are seeking a motivated Regulatory Affairs professional to join our team and help advance the clinical development of oncology products at ORIC. In this role, you will collaborate closely with colleagues across regulatory operations, quality, CMC, nonclinical and clinical functions to support high-quality, timely regulatory submissions. The ideal candidate is a proactive team player who thrives in cross-functional environments, communicates effectively, and can balance strategic thinking with strong execution. Essential duties and responsibilities include the following. Other duties may be assigned.
Requirements
- Bachelor’s degree in a scientific or related field, advanced degree preferred.
- Preferred minimum 6-8 years of regulatory affairs experience in the pharmaceutical or biotechnology industry, or a combination of an advanced degree and regulatory experience.
- Experience in preparing regulatory submissions (eg, IND, DSUR, CTA, FDA meeting requests).
- Strong communication, interpersonal, and collaboration skills across internal and external stakeholders.
- Good project management skills; able to manage multiple projects simultaneously and meet deadlines.
- High attention to detail, with excellent problem-solving and analytical thinking abilities.
- Excellent writing and editorial skills, with the ability to develop high-quality clinical-regulatory documents (eg, investigator brochures, briefing documents, IND amendments, Fast Track/ODD designation requests).
- A strong scientific background with the ability to quickly acquire knowledge in the therapeutic areas and the evolving regulatory landscape.
- Familiarity with global regulatory requirements and guidelines (FDA, ICH), with the ability to gather and analyze latest regulatory intelligence and motivated to learn new things.
- Computer expertise, including Microsoft Office Suite proficiency (eg, Word, Excel, PowerPoint).
Nice To Haves
- Experience with regulatory information management system (Veeva RIM) is a plus.
Responsibilities
- Support regulatory submissions and contribute to strategic planning for assigned programs.
- Prepare and deliver high-quality and timely regulatory submissions in compliance with applicable regulatory requirements.
- Responsible for the creation, assembly, review, and archival of complex regulatory submissions which require interaction with internal and CRO teams to ensure optimal execution.
- Develop, manage and track regulatory submission timelines.
- Collaborate cross-functionally with regulatory operations, quality, CMC, nonclinical, clinical teams.
- Ensure submissions meet standards for accuracy, completeness, and consistency, and maintain health authority correspondence archives.
- Review investigator packages and support site start-up activities from regulatory perspective.
- Expand knowledge by analyzing current regulatory issues, guidance, initiatives and effectively communicate regulatory intelligence internally.
- Contribute to the development and review of standard operating procedures to ensure regulatory compliance.
- Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
