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

Boehringer Ingelheim; Ridgefield (CT); Híbrido; USD 33 000 - 45 000; Tempo parcial

Vantagens oferecidas por esta oferta de emprego

Housing stipend

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Excellent communication

Planning and organization

Problem solving

IT literacy

Detail oriented

Formação académica

Student status (undergrad/grad/advanced)

Descrição da oferta de emprego

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&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

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.

• 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)

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com