Regulatory Affairs Intern Job at BioSpectra, Bangor, PA

WE5IenovUmVFdlZMa1hJSUorM3FwZ21MVFE9PQ==
  • BioSpectra
  • Bangor, PA

Job Description

Position Summary The Regulatory Affairs Intern assists with compilation, preparation, and organization of regulatory related documents and reports. This position is responsible for supporting the maintenance of Chemistry, Manufacturing and Control sections of regulatory submissions to global and domestic regulatory agencies. Major Roles & Responsibilities:

  • Maintains an understanding of assigned current federal, state, local and/or company regulations applicable to BioSpectra and BioSpectra products as assigned by management.
  • Supports with the Compilation of Modules 1, 2 and 3 of the eCTD filings.
  • Assists with ensuring drug master files, veterinary master files, and active substance master files are current through review of internally available documentation.
  • Assists with ensuring all BioSpectra Change Controls are included in Regulatory Submissions in a timely manner through review of the internal index and current submissions.
  • Files and Archives Regulatory Documents as required.
  • Assists with the retrieval of support documents for drug substance listing for filing to the US FDA or other global regulatory agencies as required.
  • Assists with ensuring Good Documentation Practices are followed on all regulatory submitted documentation.
  • Assists with preparation of all regulatory documents as assigned by management.
  • Assists with regulatory inspection action items.
  • Assists with ensuring Regulatory Requirements in Customer Quality Agreements are maintained in compliance for submissions.
  • Assists with the development and evolution of the Regulatory Program procedures and policies.
  • Other duties may be assigned as deemed appropriate by management.
Qualifications:
  • Student enrolled in a Bachelor's or Graduate Program in a science-related field
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Experience with relevant software applications including MS Office, Excel, and Adobe
  • Ability to communicate effectively with staff and management
  • Ability to handle sensitive information in a confidential manner
  • Close vision, distance vision, ability to adjust focus, ability to distinguish color change, and the ability to use a computer for extended periods of time.
Physical Requirements:
  • Standing for extended periods
  • Walking for extended periods
  • Sitting
  • Keyboarding
  • Regular lifting of up to 10 lbs.
  • Occasional lifting of up to 25 lbs. BioSpectra

Job Tags

Local area,

Similar Jobs

Atlas Brands

Head of Supply Chain Management Job at Atlas Brands

 ...brands that lead their categories. We manage everything in-housefrom product...  ...execution. Were looking for a Head of Supply Chain who thrives on solving real problems, keeping...  ...stay ahead of disruption. Freight & Logistics Coordination Own inbound and outbound... 

ClearPath CPA Solutions

Finance & Invoicing Agent (Part-Time, Remote - U.S. Based) Job at ClearPath CPA Solutions

&##128188; ClearPath CPA Solutions | &##128338; Hourly | &##127760; Remote Hi there! &##128075; ClearPath CPA Solutions is growing, and were looking for a reliable, detail-oriented Finance & Invoicing Agent to join our remote team. If you're someone who enjoys... 

Domino's Franchise

Delivery Driver Job at Domino's Franchise

 ...This location is West Spokane where Medical Lake, Cheney and Spokane meet at exit 2...  ...main responsibility of Domino's Pizza Delivery Driver is to deliver the orders to the designated...  ...mechanical parts, with dangerous equipment or sharp tools, and around fumes, odors... 

Lakeland Regional Health-Florida

Coding II - Inpatient - Coding & Reimbursement Job at Lakeland Regional Health-Florida

 ...Regional Health is a leading medical center located in Central Florida...  ...in healthcare. As the only Level 2 Trauma center for Polk, Highlands...  ...to join our team in various entry-level positions. Whether you'...  ...Under the direction of the Coding and Clinical Documentation Improvement... 

ProContractor Supply

Inside Sales Representative Job at ProContractor Supply

 ...At PCS, our people are our advantage. Whether its behind the counter, on the phone, or out on the road, our team shows up every day with grit, experience, and a commitment to getting it right. Backed by our dedicated fleet and trusted logistics partners, we make...