Description
The Regulatory Specialist CMO (III) is responsible for effectively:- Representing RA on project teams and providing regulatory guidance
- Clearly and convincingly communicating complex issues
- Sharing expert knowledge of complex issues
- Reviewing technical documents for cGMP and regulatory compliance
- Serving as an expert on technical matters in dealing with contract manufacturing organizations in US and abroad
- Preparing and filing high-quality submissions to regulatory authorities (A/NDA's, Supplements, Amendments, Annual Reports and DMF Updates)
- Communicating importance of quality assurance
- Provide regulatory decisions with regard to acceptability of submission documents and decisions
- Develops regulatory strategy for difficult issues which could significantly impact project timelines and costs
- Filing all applications in accordance with predetermined timelines
- Sharing with others best practices for planning, organization and time management
- Representing the company with regulatory agencies, as the agencies' primary contact for submissions
- Persuasively communicating to influence regulatory agencies
- Providing comments and perspective on proposed regulations
- Ensuring that supervisor is aware of activities and progress
- Projecting professionalism and a courteous, cheerful and cooperative demeanor
- Developing positive internal and external customer relationships
- Other duties as assigned
To find out more about Real please visit www.realstaffing.com