Hybrid CMC Regulatory Affairs Co-op: NDA/BLA Submissions

Boehringer Ingelheim; Ridgefield (CT); 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 perform regulatory submissions to US NDAs and BLAs and help improve tracking of compliance and linkage between guidelines and internal BI documents.

The role offers a hybrid schedule with two days per week in the Ridgefield office. You will work with cross-functional teams to support NDA/BLA submissions, conformance reviews, and process improvements in a collaborative

Qualifications

• Must be an undergraduate, graduate or advanced degree student in good academic standing.
• 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 students at least 9.
• Eligible to work in the United States without restriction; visa pre-approval if on a work visa may be required.

Responsibilities

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

Skills

Excellent communication

Planning and organization

Problem solving

IT literacy

Detail oriented

Education

Student status (undergrad/grad/advanced)

Job description

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

The role offers a hybrid schedule with two days per week in the Ridgefield office. You will work with cross-functional teams to support NDA/BLA submissions, conformance reviews, and process improvements in a collaborative