What are the responsibilities and job description for the Regulatory Affairs Associate III position at Katalyst CRO?
Roles & Responsibilities
- 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, SOP s, 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.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Scientific knowledge Written and verbal communication skills.
- 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.
