Intern – Regulatory Affairs jobs in United States
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Cytokinetics · 2 hours ago

Intern – Regulatory Affairs

Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on scientific innovations in muscle biology. They are seeking a highly motivated Intern to join their Regulatory Affairs group, where the intern will gain hands-on experience in regulatory operations and support ongoing regulatory submissions to global health authorities.

BiopharmaBiotechnologyHealth Care
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Veeva RIMFDA regulatory requirementsMicrosoft WordAdobe ProfessionalProject management skillsAttention to detailCommunication skills

Required

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

Company

Cytokinetics

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Cytokinetics is a biopharmaceutical company developing therapies for debilitating diseases.

H1B Sponsorship

Cytokinetics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (9)
2023 (4)
2022 (6)
2021 (7)
2020 (4)

Funding

Current Stage
Public Company
Total Funding
$2.41B
Key Investors
Royalty PharmaDeerfieldVulcan
2025-09-16Post Ipo Debt· $650M
2024-05-22Post Ipo Equity· $550M
2024-05-22Post Ipo Debt· $50M

Leadership Team

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Robert Blum
President & CEO
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Sung Lee
EVP & CFO
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Company data provided by crunchbase