CMC Regulatory Affairs Co-Op (Hybrid/On-onsite)

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

Description

Boehringer Ingelheim is currently seeking a talented and innovative co-op to join our CMC Regulatory Affairs department located at our Ridgefield facility. In this role you will perform regulatory submissions to US NDAs and BLAs and improve compliance tracking of marketed products application and improve linkage between regulatory guidelines and internal BI documents .

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees

This role would be a hybrid role with 2 days a week in office at our Ridgefield, CT office.

Duties & 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, work instructions and tools used for CMC submissions, and post-approval change processes
• Perform conformance review for compliance to CTD specifications, standards and best practice for NDAs and BLAs
• Support NDA and BLA compliance submissions

Desired Experience, Skills and Abilities:

• • 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.

Requirements

• 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.
• For students on a work visa, student must have pre-approved visa through the current college or university and eligibility to work 40 hours/week for six (6) months or more.

Eligibility Requirements:

• 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.

Compensation

This position offers an hourly wage following the table below and may come with a housing stipend if selected candidate is not local to commute to the Ridgefield, CT campus.

School Program Level
BA/BS (1st and 2nd year) $24 (OT $36)
BA/BS (3rd and 4th year) $26 (OT $39)
MA/MS/MBA $30 (OT $45)
Ph.D/Pharm.D/JD/DVM $33 (OT $49.50)