Senior Regulatory Affairs Specialist

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