Summer Intern - Regulatory Affairs

At Harmony Biosciences, we are dedicated to developing and delivering innovative therapies for people living with rare neurological diseases who have unmet medical needs. Our commitment to pursue innovative and novel treatments extends beyond clinical endpoints. We aim to address real-world patient needs with potential first-in-class and best-in-class therapies. We believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we nurture.

Harmony Biosciences' culture is defined by our core values - keeping patients at the heart of all we do, acting with integrity and ethics, working with a one-team attitude, leading with the science as we identify clinical possibilities, and delivering excellence.

This summer internship at Harmony offers a unique perspective into a rare-disease focused biotech company. Our internship program will provide you the opportunity to work on real-world projects, as well as network with people at Harmony through various events and activities.

Summary of Internship:

This position will work with the Regulatory Affairs (RA) team at Harmony. The RA team is responsible for ensuring accurate data are submitted to the US Food and Drug Administration (FDA) in a timely manner and interacting with FDA on research and development programs and initiatives. The RA team also collaborates with internal cross-functional departments to provide regulatory strategy and expertise in accordance with US FDA requirements and industry best practices.

Key Responsibilities include, but are not limited to:

• Participatein 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.

Requirements:

• 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.

PHYSICAL DEMANDS AND WORK ENVIORNMENT:

• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Ability for sustained close vision related to computer use.
• Manual dexterity for use of computers, tablets, and cell phone.
• Continuous sitting for prolonged periods; standing desk option provided.

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