About the role#
We are looking for a co-op to join our CMC Regulatory Affairs team in Ridgefield. You will work on regulatory submissions for US NDAs and BLAs. This role involves tracking compliance for marketed products and connecting regulatory guidelines to internal documents.
What you'll do#
- Review and update the Internal Reference List with ICH and US regulations, FDA guidances, and regulatory history.
- Lead projects to improve submission templates, project management tools, work instructions, and post-approval change processes.
- Perform conformance reviews to ensure NDAs and BLAs meet CTD specifications and standards.
- Support compliance submissions for NDAs and BLAs.
- Improve internal tracking of application compliance.
What you'll need#
- You must be a current undergraduate, graduate, or advanced degree student in good academic standing, enrolled for the duration of the internship.
- A cumulative GPA of 3.0 or higher is preferred.
- Undergraduate students must have completed at least 12 credit hours. Graduate students must have completed at least 9 credit hours.
- You must be at least 18 years old and legally authorized to work in the United States without restriction.
- If you are on a work visa, you must have pre-approval from your university and the ability to work 40 hours per week for at least six months.
- You must be willing to complete a drug test and post-offer physical if required.
- Strong communication, planning, and problem-solving skills are necessary.
Location & details#
- This position is based in Ridgefield, Connecticut.
- The role is hybrid, with two days per week required on-site.
- This is a paid, full-time position.
About Boehringer Ingelheim
Boehringer Ingelheim develops pharmaceutical products for humans and animals. The company operates within the pharmaceutical manufacturing industry. It was founded in 1885 and maintains its headquarters in Ingelheim am Rhein, Germany. The organization is privately held and employs over 10,000 people.
How to get in at Boehringer Ingelheim
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