Regulatory Intelligence Specialist presso Emerge Talent Cloud
Emerge Talent Cloud · Fort Collins, Stati Uniti d'America · Hybrid
- Professional
- Ufficio in Fort Collins
Purpose and Scope
With minimal oversight, the Regulatory Intelligence Specialist will review, compile, summarize and disseminate timely intelligence to a diverse company audience. The Specialist will monitor regional and global information using a Regulatory Intelligence software platform and pharma centric subscription services. The Specialist will collaborate with business stakeholders to keep the monitoring scope current to business needs, priorities, and research ad hoc topics as needed. The Specialist will work with subject matter experts to assess and identify potential actions based on intelligence findings using Continuous Improvement workflows. The Specialist will host regulatory learning opportunities and promote a culture of Regulatory Intelligence and champion proactive compliance.
Essential Duties & Responsibilities
With minimal oversight, the Regulatory Intelligence Specialist will review, compile, summarize and disseminate timely intelligence to a diverse company audience. The Specialist will monitor regional and global information using a Regulatory Intelligence software platform and pharma centric subscription services. The Specialist will collaborate with business stakeholders to keep the monitoring scope current to business needs, priorities, and research ad hoc topics as needed. The Specialist will work with subject matter experts to assess and identify potential actions based on intelligence findings using Continuous Improvement workflows. The Specialist will host regulatory learning opportunities and promote a culture of Regulatory Intelligence and champion proactive compliance.
Essential Duties & Responsibilities
- Research, collect, assess, organize, and disseminate regional and global regulatory intelligence and other related information.
- Apply regulatory knowledge to identify emerging compliance risks and opportunities.
- Initiate Veeva workflows and act as a project manager to ensure implementation of identified actions based on team analysis of intelligence.
- Maintain Regulatory Intel systems, processes, and users and update as needed to support the company’s products and goals.
- Train new users on the Regulatory Intelligence platform.
- Facilitate presentations and discussions to provide intelligence and analysis on emerging trends and risks.
- Promote a regulatory intelligence culture that supports a targeted approach to compliance.
- Facilitate the process of submitting company’s comments to applicable agencies.
- Author applicable SOPs, as necessary.
- Perform various other duties as assigned.
Knowledge, Skills & Abilities
- Knowledge and a sound understanding of regulatory and compliance functions and purpose.
- Knowledge of regulatory intelligence tools and methodologies, preferably in a pharmaceutical/device regulatory environment.
- Excellent communications skills - written and oral, able to communicate with credibility and convey complex information to a variety of audiences.
- High level of critical reasoning skills and a well-developed intuition about appropriate approaches, and risks.
- Ability to work independently and within groups.
- Ability to coordinate information from various internal and external disciplines.
- Ability to understand regulatory and technical concepts and requirements.
- Ability to perform multiple tasks on several projects.
- Ability to follow specific directions and to request instructions for complex tasks.
- Proficient knowledge of MS Office, SharePoint, and Adobe Reader/Writer.
- Veeva experience preferred.
- Bachelor's degree in a science discipline with Regulatory knowledge.
- Four or more years’ experience in the pharmaceutical/biologic industry with regulatory experience preferred.
- Hybrid (preferred) or Remote
