Regulatory Operations Specialist

• Perform archiving of regulatory submissions (US and ex-US) and health authority correspondence ensuring that documents are version-controlled and retrievable.
• Own the tracking of health authority interactions and responses in a Regulatory Information Management system.
• Perform submission publishing using eCTD publishing software and submit to health authorities (e.g. FDA Electronic Submission Gateway ESG).
• Support document publishing on various documents (including but not limited to nonclinical reports clinical study reports Investigators Brochure) using MS Word and PDF Publishing Tools.
• Conduct quality control checks on eCTD submissions including hyperlinking bookmarking and validation against technical specifications.
• Assist with the maintenance and management of electronic document management systems and publishing systems.
• Stay up-to-date with evolving global regulatory requirements guidelines and industry trends that could impact regulatory submissions and approval timelines.

Perform all duties in keeping with the Companys core values policies and all applicable regulations.

Qualifications :

• 1-3 years industry experience in industry-related position. BS Degree in relevant field (or equivalent).
• Experience supporting regulatory affairs processes and systems for clinical and commercial activities.
• Knowledge and hands on experience using Regulatory Information Management systems (e.g. Veeva RIM) or regulatory submission publishing systems is a plus.
• Effective oral and written communication skills. Strong interpersonal skills. Ability to successfully solve challenging issues perform critical thinking and be detail oriented.

Excellent organizational ability can easily multitask and shift priorities as needed.

Additional Information :

The anticipated base salary for candidates who will work on-site at our San Diego location is between $80000-$90000 per year. The final rate offered to a successful candidate will be dependent on several factors that may include title type and length of experience within the role type and length of experience within the industry education geography and other job-related factors. This position is not eligible for H-1B visa sponsorship.

ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristics.

Remote Work :

No

Employment Type :

Full-time