CMC Regulatory Affairs Co-Op Fall (Hybrid)
Boehringer Ingelheim
- Ridgefield, CT
- $20.00-33.00 per hour
- Training
- Full-time
- Review and update the Internal Reference List with relevant ICH and US regulations, and FDA Guidances, Q&A/s, preambles and regulatory history
- Annotate submission templates to link references to the applicable US-specific content requirements.
- Perform a conformance review of a BLA for compliance to CTD specifications, standards and best practice, including creation of an FDA Reviewer's Guide summarizing revisions to the dossier.
- 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.
- Overall cumulative minimum GPA from last completed quarter/semester 3.0 GPA (on a 4.0 scale) preferred.
- Major or minor in related field of internship
- Undergraduate students must have completed at least 12 credit hours at current college or university.
- Graduate and advanced degree students must have completed at least 9 credit hours at current college or university.
- Excellent communication (verbal and written) skills
- Excellent skills in planning, organizing, and problem-solving
- Computer and information technology literacy
- Ability to work well under pressure, work in a team environment, flexibility to adapt in a changing environment.
- Detail oriented, well organized.
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required)
- Must be 18 years of age or older