Columbus, OH, US
4 days ago
Internship -Regulatory Affairs

Location: Columbus On-Site

Job Type: 2025 Summer Intern

Req ID: 7473

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 750 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated College Summer Intern for our Regulatory Affairs team at our Columbus, Ohio site. As an Intern, you will earn practical experience as a fully integrated member of our team and participate in meaningful projects that will add value to our organization. In this role, you will provide support to the various Regulatory Affairs groups.

 

Responsibilities

 

Regular and predictable attendance and punctuality Works closely with Development Regulatory team to provide regular updates on tasks Inputs meta data for products into the RIM system Assists in maintenance of deficiency database for deficiencies received from Health Authorities Assists in submission related document coordination, creation/maintenance of submission templates, preparation of change control management tracking list for Health Canada submissions Works closely with development regulatory team in maintenance of submission templates for FDA submissions Assists in eCTD publishing preparation of documents for submissions to Health Authorities Other duties as assigned

Qualifications/Requirements (i.e. education, technical skills)):

Must be an Undergraduate, Graduate, or Professional Student in good academic standing. Must have completed 12 credit hours within a related major and/or other related coursework. Overall, cumulative GPA must be at least 3.0 (on 4.0 scale) or better. Pursuing degree in a scientific discipline Must be able to demonstrate effective communication skills. Strong mathematical, analytical, and problem-solving abilities. Highly motivated and inquisitive with a strong desire to learn. Organization skills to manage multiple tasks with strong attention to details. Planning and organizational skills. Proficient usage of Microsoft Office applications. Must be legally authorized to work in the United States without restriction, no sponsorship offered at this time. Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background. Must be willing to take a drug test. Must be 18 years of age or older.

 

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Confirm your E-mail: Send Email