Job Description

The Regulatory Operations Specialist is responsible for supporting the preparation, formatting, publishing, and submission of regulatory documents to global health authorities. This role ensures compliance with electronic submission standards and contributes to the efficiency and quality of regulatory filings. The Specialist will work collaboratively with cross-functional teams to meet submission timelines and regulatory requirements.

Essential duties and responsibilities include the following. Other duties may be assigned.

• Support document publishing on various documents (including but not limited to nonclinical reports, clinical study reports, Investigator’s Brochure) using MS Word and PDF Publishing Tools.
• Perform submission publishing using eCTD publishing tools and submit to regulatory agencies as required (e.g., FDA Electronic Submission Gateway [ESG]).
• Support the timely submission of high-quality and compliant regulatory submissions to regulatory agencies.
• Perform regulatory operations tracking of submission (US and ex-US), agency correspondence, nonclinical reports, protocol number/clinical trial assignment and other regulatory operations activities as identified. Ensure proper documentation, archiving, and tracking of all regulatory submission materials and correspondence, ensuring accessibility and compliance with record retention policies.
• Assist in the development and maintenance of submission templates, style guides, and SOPs to ensure consistency across regulatory filings.
• Support the validation and implementation of regulatory publishing software and tools.
• Support 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 Company’s core values, policies and all applicable regulations.

Qualifications

Education and Experience:

• 2-5 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.
• Working knowledge of GXP Federal Regulations including 21 CFR Part 11 regulations.
• Knowledge and hands on experience in electronic submission publishing systems such as EXTEDO, Lorenz, or Veeva 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 salary range for candidates is between $70,000-$100,000 The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc.

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 characteristic.