CMC Regulatory Co-op: NDA/BLA Submissions & Compliance

BioCT Innovation Commons; Ridgefield, Northern (CT, KY); Hybrid; USD 33,000 - 45,000; Part time

Benefits offered by this job

Housing stipend

Job summary

Boehringer Ingelheim is seeking a talented co-op to join our CMC Regulatory Affairs team at the Ridgefield, CT facility. You will assist with regulatory submissions to US NDAs and BLAs and help improve compliance tracking and linkage between regulatory guidelines and BI documents.

The role is hybrid with 2 days per week in the Ridgefield office. The position offers exposure to global regulatory operations and collaboration across BI functions, contributing to our mission to deliver medicines to

Qualifications

• Must be a current undergraduate, graduate or advanced degree student in good academic standing.
• Student must be enrolled at a college or university for the duration of the internship.
• GPA 3.0 (on a 4.0 scale) preferred.
• Major or minor in related field of internship.
• Undergraduate students must have completed at least 12 credit hours.
• Graduate/advanced degree students must have completed at least 9 credit hours.

Responsibilities

• Review and update the Internal Reference List with relevant ICH and US regulations, and FDA Guidances, Q&A, preambles and regulatory history.
• Lead improvement projects related to NDA and BLA submission templates, submission project management tools, and post-approval change processes.
• Perform conformance review for CTD specifications, standards and best practices for NDAs and BLAs.
• Support NDA and BLA compliance submissions.

Skills

Communication

Planning

Problem solving

IT literacy

Teamwork

Attention to detail

Education

Undergraduate or graduate student

GPA 3.0

Related field of internship

Credit hours completed

Job description

Boehringer Ingelheim is seeking a talented co-op to join our CMC Regulatory Affairs team at the Ridgefield, CT facility. You will assist with regulatory submissions to US NDAs and BLAs and help improve compliance tracking and linkage between regulatory guidelines and BI documents.

The role is hybrid with 2 days per week in the Ridgefield office. The position offers exposure to global regulatory operations and collaboration across BI functions, contributing to our mission to deliver medicines to