As a Specialist in Regulatory Affairs, you will be responsible for creating and reviewing regulatory documentation for the renewal of drugs, devices, and combination products. You will collaborate with various support groups and manage the status and progress of regulatory documentation. This role involves coordinating responses to regulatory authority questions, using electronic document management systems, and maintaining a database of regulatory requirements.
Key Responsibilities
- Documentation Management: Create and review regulatory documents for product renewals.
- Interdepartmental Collaboration: Interact with manufacturing, product stability, quality, clinical, and other non-regulatory support groups to obtain necessary documentation.
- Tracking and Coordination: Track the status and progress of regulatory documentation and compile responses to regulatory authority renewal questions under supervision.
- Electronic Systems: Use an electronic document management system to compile and manage documents for submission to Health Authorities.
- Internal Support: Respond to internal queries regarding assigned products.
- Database Maintenance: Maintain a database of regulatory requirements for renewals.
- Risk Management: Independently identify and resolve or escalate compliance risks.
Required Skills and Qualifications
- Regulatory Knowledge: Strong understanding of regulations and scientific knowledge.
- Project Management: Effective administrative and project management skills with the ability to contribute to multiple projects.
- Multitasking: Ability to prioritize and manage multiple tasks effectively.
- Interpersonal Skills: Strong communication and interpersonal skills.
- Technical Proficiency: Proficiency in technical systems, including word processing, spreadsheets, databases, and online research.
- Proofreading: Excellent proofreading and editing skills.
- Compliance Awareness: Ability to identify compliance risks and take appropriate actions.