Medical Affairs Assistant
3 days ago
Are you a detail-oriented and organized individual with a passion for regulatory compliance? Do you have a background in pharmacy and experience in document processing?
Job SummaryWe are seeking a skilled Regulatory Assistant to join our team at RBGM Medical Express Sales, Inc. In this role, you will assist in the preparation of regulatory documents and submissions, ensuring accuracy and compliance with FDA requirements.
Main Responsibilities- Coordinate with third-party principals to gather required regulatory documents, following up as necessary to meet deadlines.
- Document and track all responses received from principals, ensuring all necessary information is complete for FDA submission.
- Prepare submission documents under the guidance of the Regulatory Supervisor, ensuring accuracy and compliance with FDA requirements.
- Maintain a well-organized database of documents for easy retrieval and submission tracking throughout the regulatory process.
To succeed in this role, you will need a Bachelor's degree in Pharmacy and at least 6 months of experience in coordination and document processing. A license to practice pharmacy is also essential.
In addition, you will require strong analytical and problem-solving skills, excellent written and verbal communication skills, and the ability to work effectively in a team environment.
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