
Regulatory Affairs Specialist
1 day ago
Regulatory Affairs Team Member Job Description
About the RoleWe are seeking a highly skilled Regulatory Affairs team member to join our project teams. As a key member of the team, you will play a critical role in ensuring compliance with regulatory requirements and contributing to the success of our projects.
Key Responsibilities- Regulatory Project Plan Execution: Supports the execution of regulatory project plans to ensure timely and cost-effective delivery.
- Maintaining Regulatory Awareness: Maintains awareness of regulatory requirements and stays up-to-date with changes and updates to ensure continued learning.
- Regulatory File Management: Ensures that regulatory files are maintained in a format consistent with requirements.
- Team Collaboration: Participates as an active team member of project teams as required, providing support and expertise to drive project success.
- Response Preparation: Compiles and prepares responses to questions from regulatory authorities according to plan.
- Documentation Editing: Edits and proofreads regulatory documentation to ensure accuracy and quality.
- Labeling and SOP Support: Assists in preparation and review of labeling, SOPs, and other departmental documents.
- Document Submission: Compiles under supervision regulatory documents for submission.
- Status Tracking: Tracks status and progress of regulatory documentation.
- Strong Knowledge of Regulatory Requirements: Possesses a deep understanding of regulatory requirements and standards.
- Excellent Communication Skills: Demonstrates excellent communication and interpersonal skills to effectively collaborate with cross-functional teams.
- Attention to Detail: Shows attention to detail and ability to manage multiple tasks and priorities.
- Continuous Learning: Embraces continuous learning and professional development to stay current with changing regulatory landscape.
This role offers a competitive salary, opportunities for growth and development, and a collaborative work environment.
How to ApplyTo be considered for this exciting opportunity, please submit your application through our online portal. We look forward to reviewing your qualifications and experience.
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