Regulatory Operations Specialist

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 crossfunctional 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 Investigators 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 highquality and compliant regulatory submissions to regulatory agencies. 
• Perform regulatory operations tracking of submission (US and exUS) 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 uptodate 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 :

Education and Experience: 

• 25 years industry experience in industryrelated 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 $70000$100000 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.  

Remote Work :

No

Employment Type :

Fulltime