Intern – Regulatory Affairs

Cytokinetics • Radnor, PA

7d • Onsite

About The Position

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. We are seeking a highly motivated Intern to join our Regulatory Affairs group at Cytokinetics. Job Description: The Regulatory Operations internship is designed to give students hands-on insights and working experience of several regulatory operations and affairs functions including Regulatory Systems, Regulatory Project Management, Regulatory Publishing, and Regulatory Strategy. Interns will work closely with these functions to support ongoing regulatory submissions to global health authorities, as well as department projects that support process initiatives. Systems Support day-to-day user management of Cytokinetics regulatory document management system, Veeva RIM Learn various features of Veeva RIM Sit in on project meetings for rollout of new configurations Project Management Assist with building and managing a submission content plan in Veeva RIM Support planning and coordination various documents for submissions to global health authorities. Publishing Gain insight into the publishing process such as document formatting/linking, validation, and transmission of submission to the global health authorities. Learn how to eQC (electronic Quality Check) a regulatory submission Strategy Read various health authority questions and responses Shadow a regulatory affairs strategist to gain insights

Requirements

• The position requires a motivated individual with the ability to work independently and in a team environment.
• Pursuing BS degree in Life Sciences (e.g. Biology, Chemistry) or Business
• Proficiency with Microsoft Word, Adobe Professional, and other information technology systems are highly desirable.
• Familiarity with FDA regulatory requirements (e.g., IND, NDA, orphan drug designation).
• Strong attention to detail and ability to manage tasks within defined deadlines
• Demonstrated basic project management skills
• Excellent communication skills and the ability to troubleshoot problems with team members
• Ability to be on site in our Radnor, PA office

Responsibilities

• Systems Support day-to-day user management of Cytokinetics regulatory document management system, Veeva RIM
• Learn various features of Veeva RIM
• Sit in on project meetings for rollout of new configurations
• Assist with building and managing a submission content plan in Veeva RIM
• Support planning and coordination various documents for submissions to global health authorities.
• Gain insight into the publishing process such as document formatting/linking, validation, and transmission of submission to the global health authorities.
• Learn how to eQC (electronic Quality Check) a regulatory submission
• Read various health authority questions and responses
• Shadow a regulatory affairs strategist to gain insights

What This Job Offers

• Career Level: Intern
• Number of Employees: 251-500 employees