Regulatory Affairs Specialist Job at Swoon, Deerfield, IL

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  • Swoon
  • Deerfield, IL

Job Description

Title: Regulatory Affairs Ops Specialist

Pay: $37-$45.50

Type: Hybrid

Duration: 12 months

Key Responsibilities:

  • Under limited supervision responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions.
  • Produces and evaluates technical and scientific data necessary for regulatory submissions.
  • Assists in the implementation and delivery of new or upgraded systems and processes in support of companies products.
  • Document all system related issues, and identify resolutions
  • Document complex processes and create and manage documentation related to validated systems
  • Participate in identifying solution to meet requirements for systems - Participate in system upgrades to assure integrity of data is maintained
  • Assure adequate access and functioning of system tools and version upgrades - Provides expertise in ongoing maintenance of electronic record receipt and submission to regulatory authorities
  • Participate as an active team member and provide expertise to project teams as required
  • May verify the maintenance of support systems, libraries and dictionaries - Maintain awareness of regulatory requirements and evaluate potential impact to company

Qualifications:

  • Bachelor's Degree or country equivalent with a minimum of 5 years in a regulated environment.
  • Scientific or related discipline would be an advantage.
  • Detail oriented
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Written and verbal communication skills
  • Knowledge of applicable regulations
  • Excellent organizational skills and ability to support multiple projects
  • Ability to contribute to multiple projects from an operations perspective
  • Work independently with minimal direct supervision
  • Strong negotiation and collaboration skills
  • Manage multiple projects and deadlines
  • Ability to identify compliance risks and resolve or escalate when necessary
  • Experience in addressing complex problems or processes

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