Summer Intern - Regulatory Affairs jobs in United States
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Harmony Biosciences · 1 day ago

Summer Intern - Regulatory Affairs

positionPlymouth Meeting, PA
timeInternship
remoteOnsite
seniorityIntern

Harmony Biosciences is dedicated to developing innovative therapies for rare neurological diseases. This summer internship offers an opportunity to work with the Regulatory Affairs team, ensuring timely submission of data to the FDA and collaborating on regulatory strategy and initiatives.

BiopharmaBiotechnologyHealth Care

Responsibilities

Participate in cross-functional meetings and contribute to deliverables related to research and development initiatives for clinical studies; Chemistry, Manufacturing and Controls (CMC); promotional materials; and regulatory strategy
Assist with regulatory submissions and activities, including review and submission of clinical study reports, study protocols, protocol amendments, and regulatory information amendments
Navigating the Regulatory Information Management (RIM) system
Work with assigned mentors on projects to stimulate problem solving and critical thinking skills
Assist with other projects as needed to support the regulatory team

Qualification

Regulatory submissionsMS ExcelMS PowerPointMS TeamsInterpersonal skillsWritten communicationVerbal communicationProblem solvingCritical thinkingTeam collaboration

Required

Minimum age for all candidates must be at least 18 years or older
Must be enrolled in an accredited college or university as a rising sophomore, junior or senior; majoring in science or engineering is preferred
Must be proficient in use of MS Excel, MS Power Point, MS Teams
Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
Candidates must have strong written and verbal communication skills

Company

Harmony Biosciences

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Harmony Biosciences is a pharmaceutical company that develops and commercializes novel therapies for rare neurological disorders.
dateFounded in 2017
location
Plymouth Meeting, Pennsylvania, USA
people-size201-500 employees
web-link
https://www.harmonybiosciences.com

Funding

Current Stage
Public Company
Total Funding
$1.68B
Key Investors
Blackstone Life SciencesBlackstone GroupOrbiMed
2024-10-30Post Ipo Secondary· $248M
2023-07-27Post Ipo Debt· $185M
2021-11-01Post Ipo Equity· $200M

Leadership Team

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Jeffrey M. Dayno
President & Chief Executive Officer
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Recent News

Longevity.Technology - Latest News, Opinions, Analysis and Research
Beacon Biosignals partners with Harmony Biosciences to add EEG into hypersomnia Phase 3 trials
2025-12-19
GlobeNewswire
Beacon Biosignals Announces Partnership with Harmony Biosciences to Advance Objective Clinical Endpoints in Hypersomnia Conditions Through Quantitative EEG
2025-12-16
MarketScreener
Harmony Biosciences, Beacon Biosignals Collaborate on Phase 3 Trials in Narcolepsy, Hypersomnia
2025-12-16
Company data provided by crunchbase