CMC Regulatory Affairs Co-Op (Hybrid)
Boehringer Ingelheim GmbH, Ridgefield, CT, United States
Boehringer Ingelheim is currently seeking a talented and innovative co-op to join ourCMC Regulatory Affairsdepartment located at ourRidgefieldfacility. In this role you willperform 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 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&As, preambles and regulatory history
Lead improvement projects related to: NDA and BLA submission templates, submission project managment 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
Requirements
Must be a current undergraduate, graduate or advanced degree student in good academic standing.
Student must be enrolled at an accredited college or university for the duration of the
internship/co-op .
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/co-op .
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.
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.
Desired Skills, Experience 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.
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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 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&As, preambles and regulatory history
Lead improvement projects related to: NDA and BLA submission templates, submission project managment 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
Requirements
Must be a current undergraduate, graduate or advanced degree student in good academic standing.
Student must be enrolled at an accredited college or university for the duration of the
internship/co-op .
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/co-op .
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.
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.
Desired Skills, Experience 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.
#J-18808-Ljbffr