Regulatory Affairs Associate III Position 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.
- 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
- Bachelors degree or country equivalent in pharmacy or related scientific discipline with 0-2 years regulatory experience, preferably within a healthcare environment.
- 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
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.