Regulatory Affairs Associate
Proclinical is currently recruiting for a Regulatory Affairs Associate with a biopharmaceutical company located in Rockville, MD.
- Analyst, Regulatory Policy and Intelligence RPI manages and maintains a variety of databases and communication platforms supporting RPI projects and services.
- Conducts daily scanning of regulator websites for U.S. and Canada for regulatory intelligence and enters relevant information into RPI's regulatory intelligence platform.
- Supports RPI approval trending analysis by entering appropriate information into databases.
- Supports searches of regulatory intelligence sources to support senior RPI staff.
- Prepares supporting material for RPI staff on regulatory policy topics.
- Supports other regulatory intelligence activities as needed.
- Creates and manages IT platforms to share information and manage RPI services and projects, e.g., Excel, SharePoint, Planner, Teams.
- Develops and maintains templates for RPI materials to ensure consistency in information sharing within RPI and between RPI and other internal customers.
- Manages the development and communication of regulatory policy newsletters and other relevant information.
- Manages routine RPI meetings by supporting development of agenda, background materials, and meeting summaries.
- Serves as back up office manager/administrative assistant.
- Coordinates and provides support in implementing various RPI projects.
Skills and Requirements:
- Required Education: High School diploma or equivalent and 4 years' experience or bachelor's degree.
- Preferred Education: Bachelor's degree or Associate degree w/ at least 2 years of experience in a related role.
- Required Experience: Strong command of SharePoint, Teams, Word, PowerPoint, and Excel. Demonstrated competency in distilling large amounts of information into concise executive summaries.
- The incumbent should also be comfortable working in an environment where they can proactively bring forward new process and technology improvements for RPI services and communications.
- Excellent communicator in written and verbal forms. Excellent organizational skills. Ability to work in a complex / matrix environment.
- Preferred Experience: 2 years' experience in an industry related role; Experience in designing and implementing new processes/databases/platforms and creating appropriate communications based on distilled information.
- Note: Higher education may compensate for years of experience and vice versa.
If you are having difficulty in applying or if you have any questions, please contact Dominic Santoro at 215-531-5280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.