Regulatory Affairs Specialist

Chipton-Ross is seeking a Regulatory Affairs Specialist III for a remote contract opportunity.

JOB SUMMARY:
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.

RESPONSIBILITIES:
- 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.

REQUIREMENTS:
- 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.

EDUCATION:
Accredited Bachelor's Degree required

WORK HOURS:
First shift, full time