Regulatory Affairs Professional
7 days ago
5TH HQ LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. This role is critical in ensuring compliance with regulatory requirements and advancing product approvals.
Key Responsibilities:
- Document Preparation: Prepare, review, and submit regulatory documents to ensure adherence to FDA and international regulations.
- Knowledge Management: Stay up-to-date on the latest regulatory guidelines, standards, and industry developments.
- Submission Coordination: Assist in the preparation of regulatory submissions, including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), and amendments.
- Cross-Functional Collaboration: Coordinate with cross-functional teams to gather necessary information for regulatory submissions.
- Communication: Ensure timely and accurate communication with regulatory authorities.
- Progress Monitoring: Monitor and track the progress of submissions and respond to inquiries from regulatory bodies.
- Strategic Development: Assist in the development and implementation of regulatory strategies to support product approvals and lifecycle management.
- File Maintenance: Maintain accurate and organized regulatory files and records.
Requirements
To be successful in this role, you will need:
- A Bachelor's degree in a related field such as biology, chemistry, or pharmaceutical sciences.
- Previous experience in a regulatory affairs role within the pharmaceutical industry is preferred.
- A strong understanding of FDA regulations and guidelines.
- Excellent organizational and time management skills.
- Strong attention to detail and ability to handle multiple projects simultaneously.
- Effective communication skills, both written and verbal.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and as part of a team.
Compensation: The estimated salary for this position is $85,000 - $110,000 per year, depending on experience and qualifications.
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