What are the responsibilities and job description for the Regulatory Affairs Associate position at Integration International Inc.?
Job Details:
Title: Regulatory Affairs Associate III
Location: Skaneateles, NY 13153 (Can be fully remote or hybrid)
Duration: 12 months
Description:
- Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions.
- Review and evaluate technical and scientific data and reports required for submission in support of companies products. This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
- Track of status and progress of regulatory documentation
- Review, edit and proofread regulatory documentation
- Assist in preparation and review of labeling, SOPs, and other departmental documents
- Compile under supervision regulatory documents for submission
- Participate as an active team member of project teams as required
- Compile and prepare responses to regulatory authorities questions
- Maintain regulatory files in a format consistent with requirements
- Maintain awareness of regulatory requirements
- May be responsible for a specific product portfolio in the region to perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
List knowledge, skills, and/or abilities required:
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Scientific knowledge
- Written and verbal communication skills
- Knowledge of regulations
- Technical systems skills (e.g. word processing, spreadsheets, databases, online research)
- Proofreading and editing skills
- Ability to contribute to multiple projects from a regulatory affairs perspective
- Ability to multitask and prioritize Include the education and experience that is necessary to perform the job satisfactorily.
- Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with 0-2 years regulatory experience, preferably within a healthcare environment.
