Regulatory Intelligence Specialist

The Fountain Group is currently seeking a ------Regulatory Intelligence Specialist for a prominent client of ours. This position is located in --South San Francisco , CA. Details for the position are as follows:

Job Title: Regulatory Intelligence Specialist

Location: South San Francisco, CA (Onsite - No Exceptions)

Pay Rate: $19.05 - $34.06/hr

Duration: 1 Year Contract (Renewable up to 3 Years)

Client is open to recent BS/MS graduates in Regulatory affairs or related filed or intern or academic experience in regulatory affairs

Job Description

The Regulatory Intelligence Specialist supports global Regulatory Intelligence operations by monitoring, analyzing, and disseminating regulatory updates impacting pharmaceutical and biotech development programs. The role involves tracking health authority communications (FDA, EMA, and other global agencies), competitor regulatory activities, and compliance changes. Responsibilities include synthesizing regulatory data into structured intelligence reports, maintaining regulatory databases, supporting dashboards and reporting tools, and ensuring audit-ready documentation. The role requires hands-on experience with regulatory tracking systems and structured data management in a highly regulated environment.

Education

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, Biotechnology, or related scientific discipline
  
  

Required Skills

• Regulatory intelligence monitoring across FDA, EMA, and global health authorities
• Experience tracking regulatory updates, guidances, approvals, and labeling changes
• Competitor regulatory surveillance (filings, approvals, pipeline monitoring)
• Regulatory data management and documentation control in systems like Veeva Vault or equivalent
• Regulatory database maintenance, validation, and quality control
• Creation of regulatory intelligence reports, summaries, and structured briefings
• Development and maintenance of regulatory trackers and dashboards
• Familiarity with regulatory information sources (health authority portals, scientific/regulatory databases)
• Structured data categorization and taxonomy for regulatory content
• Audit-ready documentation practices in regulated environments
• Use of digital tools and AI-assisted platforms for regulatory data aggregation and summarization
  
  

Preferred Skills

• Experience supporting Regulatory Affairs, Clinical, or Drug Development teams
• Exposure to regulatory intelligence platforms or enterprise content management systems
• Experience building reporting dashboards (e.g., BI or visualization tools)
• Knowledge of global pharmaceutical regulatory frameworks and submission lifecycle
• Experience handling high-volume regulatory data in fast-paced biotech/pharma environments
  
  

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