Temp - Regulatory Information Management Archives

Location
Tarrytown, NY, United States
Posted
Aug 28, 2020
Ref
19742BR
Required Education
Bachelors Degree
Position Type
Contract
Summary
Responsible for archiving (categorizing and classifying information) Regulatory records pertaining to multiple Regulatory Applications (INDs, BLAs, etc.), maintaining Regulatory application indexes, tracking of regulatory documents, and assisting with special projects as needed.

Responsibilities
  • Manage and maintains electronic and paper archives for Regulatory submissions, submission documents, and related correspondence for multiple Regulatory Applications (INDs, BLAs, etc.)
  • With some guidance, maintain and ensure Regulatory information is accurate in Regulatory systems.
  • Scan paper documents into PDF format, OCR's the PDFs, and upload the PDFs into the Regulatory Document Management System (DMS).
  • Support archive projects such as migrating previously scanned paper submissions, legacy documents, and archive index information into the Regulatory DMS.
  • Collaborate with the RIM Process team and key stakeholders.
  • Communicate key RIM-related information to consumers, collect feedback, and take action.
  • Work to ensure regulatory data is compliant with defined standards, policies and quality requirements
  • Assist with user training.
  • Assist with managing paper archives.
  • Assist with managing RIM knowledge objects.
  • Identify and communicate regulatory system enhancement needs or technical issues.
  • 2 -5 years of relevant regulatory information management experience with applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., FDA, EMA, ICH) and drug development process.
  • Bachelor's degree in a related field.
  • Knowledge of pharmaceutical drug and device development process.
  • Knowledge of categorization and classifying information.
  • Ability to contribute to improvement initiatives
  • Experience in Regulatory Affairs/Operations/information preferred.
  • Knowledge and practical experience in global submissions and principles of information systems preferred.
  • Knowledge of scientific industry terminology and how to effectively use as metadata preferred.
  • Knowledge of relationships between key components of Regulatory Information preferred.
  • Ability to manage, and/or contribute to multiple ongoing projects simultaneously
  • Knowledge of technical writing is preferred
  • Knowledge of 21 CFR Part and Annex 11 Regulations is preferred
  • Can work independently, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.
  • Possess energy and drive, strong operating skills, strong personal and interpersonal skills, strong critical thinking, and strong strategic skills

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

-