Haleon
Co-Op, Regulatory Affairs Associate (12-months, January 2025 Start)
Haleon, Trenton, New Jersey, United States,
Co-Op, Regulatory Affairs Associate (12-months, January 2025 Start)Locations: USA - New Jersey - Warren
Time Type: Full time
Posted on: Posted 5 Days Ago
Hello. We’re Haleon. A new world-leading consumer healthcare company. Together, we’re improving everyday health for millions of people by growing and innovating our global portfolio of category-leading brands.
A career in Regulatory Affairs where none of us stand still.
Regulatory Affairs Overview
Regulatory Affairs plays an important role across many industries. Within Consumer Healthcare, it ensures companies continuously supply products that are of proven safety, efficacy, and quality.
Regulatory Affairs Co-Op
The objective of the Regulatory Affairs Co-Op role will be to provide a systematic review and categorization of archived FDA regulatory correspondences and other documents. This role will be instrumental in providing an efficient way to access this information.
This role will provide the Associate with the opportunity to learn about FDA submission documentation, including a high-level overview of regulatory components for both Investigational New Drugs (INDs) and New Drug Applications (NDAs).
The Regulatory Affairs Co-Op will be responsible for the following activities:
Track and categorize FDA eCTD submissions across all Haleon INDs and NDAs.
Track, categorize and upload FDA Correspondences.
Track and categorize FDA paper-based submissions located in hard copy.
Categorize the FDA questions by topic across all INDs and NDAs.
Retrieve and consolidate historical regulatory documents and assessments on pertinent projects.
What will your individual contribution at Haleon be?
Work within Haleon systems (Veeva and TRS) to retrieve archived FDA documentation.
Utilize Haleon archival systems to upload and store FDA correspondences.
Prepare and maintain detailed spreadsheets to capture the chronological history of FDA information.
Present to USRA team a summary of insights from review of historical FDA documentation.
To enable you to perform in this future talent opportunity:
Minimal Requirements:
Enrolled in bachelor’s degree program studying in Science, Biology, Pharmacy or related field.
Experience working in Microsoft Word and Excel.
Detail oriented and ability to manage multiple tasks simultaneously.
Must be able to work full-time (40 hours/week) Monday-Friday for duration of 12 months.
Ability to start in January 2025.
Provide your own funding for relocation and commuting.
This role is onsite at our Warren, NJ location.
A cumulative GPA of 3.0 is preferred.
Must be eligible to work in the US at the time of, and for the duration of employment.
Expected start date:
January 2025
The hourly rate for this role is
$24.50/hour.
We invite you to apply as soon as possible. We accept ongoing applications and will close this vacancy once we have enough applications.
At Haleon, we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives. We believe in an agile working culture for all our roles.
Haleon is an Equal Opportunity Employer. We adhere to Affirmative Action principles to ensure that all qualified applicants will receive equal consideration for employment.
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Time Type: Full time
Posted on: Posted 5 Days Ago
Hello. We’re Haleon. A new world-leading consumer healthcare company. Together, we’re improving everyday health for millions of people by growing and innovating our global portfolio of category-leading brands.
A career in Regulatory Affairs where none of us stand still.
Regulatory Affairs Overview
Regulatory Affairs plays an important role across many industries. Within Consumer Healthcare, it ensures companies continuously supply products that are of proven safety, efficacy, and quality.
Regulatory Affairs Co-Op
The objective of the Regulatory Affairs Co-Op role will be to provide a systematic review and categorization of archived FDA regulatory correspondences and other documents. This role will be instrumental in providing an efficient way to access this information.
This role will provide the Associate with the opportunity to learn about FDA submission documentation, including a high-level overview of regulatory components for both Investigational New Drugs (INDs) and New Drug Applications (NDAs).
The Regulatory Affairs Co-Op will be responsible for the following activities:
Track and categorize FDA eCTD submissions across all Haleon INDs and NDAs.
Track, categorize and upload FDA Correspondences.
Track and categorize FDA paper-based submissions located in hard copy.
Categorize the FDA questions by topic across all INDs and NDAs.
Retrieve and consolidate historical regulatory documents and assessments on pertinent projects.
What will your individual contribution at Haleon be?
Work within Haleon systems (Veeva and TRS) to retrieve archived FDA documentation.
Utilize Haleon archival systems to upload and store FDA correspondences.
Prepare and maintain detailed spreadsheets to capture the chronological history of FDA information.
Present to USRA team a summary of insights from review of historical FDA documentation.
To enable you to perform in this future talent opportunity:
Minimal Requirements:
Enrolled in bachelor’s degree program studying in Science, Biology, Pharmacy or related field.
Experience working in Microsoft Word and Excel.
Detail oriented and ability to manage multiple tasks simultaneously.
Must be able to work full-time (40 hours/week) Monday-Friday for duration of 12 months.
Ability to start in January 2025.
Provide your own funding for relocation and commuting.
This role is onsite at our Warren, NJ location.
A cumulative GPA of 3.0 is preferred.
Must be eligible to work in the US at the time of, and for the duration of employment.
Expected start date:
January 2025
The hourly rate for this role is
$24.50/hour.
We invite you to apply as soon as possible. We accept ongoing applications and will close this vacancy once we have enough applications.
At Haleon, we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives. We believe in an agile working culture for all our roles.
Haleon is an Equal Opportunity Employer. We adhere to Affirmative Action principles to ensure that all qualified applicants will receive equal consideration for employment.
#J-18808-Ljbffr