Regulatory Affairs Specialist jobs in Danbury, CT

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 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 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/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.

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.

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.
  

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

The position offers an hourly rate typically between $20/hour and $33/hour commensurate to the level of degree program in which an applicant is actively enrolled.