Regulatory Affairs Ops Specialist II Job at Planet Group, Hainesville, IL

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  • Planet Group
  • Hainesville, IL

Job Description


Target Pay Rate: 35-38.87/hr **salary will be commensurate with experience 

Summary:

Responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of products. Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects.

Essential Duties and Responsibilities:

This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
  • Initiate and develop complex regulatory project plans
  • Identify & prioritize key areas of regulatory risk
  • Monitor applicable regulatory requirements
  • Create and maintain regulatory files in a format consistent with requirements
  • Provide regulatory advice to project teams.
  • Respond to complex questions from regulatory authorities within strict timelines
  • Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
  • Maintain and update existing regulatory authorizations
  • Manage regulatory activities relating to specific portfolio of products/projects
  • Prepare, review, and approve labeling and SOPs
  • Lead or represent Regulatory Affairs in project teams
  • Provide guidance and coaching for areas of responsibility to lower level team members
Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. 0 N/A: Intern or Co-op
    • Knowledge of regulations
  • Scientific knowledge
  • Project management skills
  • Manage multiple projects and deadlines
  • Ability to multitask and prioritize
  • Interpersonal and communication skills
  • Strong negotiation skills
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Ability to work effectively in multinational/multicultural environment
  • Ability to identify compliance risks and escalate when necessary
Education and/or Experience:

Bachelors degree or country equivalent in a scientific discipline Minimum of 5 years regulatory experience within a pharmaceutical company for medicinal products, CRO, or similar organization. FDA regulations and knowledge

Job Tags

Remote job, Contract work,

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