Director of Regulatory Affairs - Conshohocken, PA
The Sr. Director/Director of Regulatory Affairs will provide regulatory support for products in development and/or marketed products. The Sr. Director/Director RA will have high level writing skills, and will be responsible for writing and submission of regulatory documents including INDs, NDAs/sNDAs, briefing documents for meeting with HA, annual reports, amendments, supplements, clinical protocols and clinical study reports. * Participate on multidisciplinary teams and communicate regulatory requirements effectively. * Conduct regulatory intelligence research to assist in the development of strong regulatory strategies. * Review regulatory documents associated with clinical research * Evaluate change controls for drug substances, drug products, test methods and manufacturing and provide the regulatory impact assessment. * Prepare regulatory submissions. * Develop and/or review SOPs, policies, and guidelines to ensure compliance with newly issued or revised regulations and guidance documents.
Qualifications: Masters or PhD Degree in a scientific discipline. 5+ Years within the pharmaceutical industry, at least 3 years in regulatory affairs
Our people are everything. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With over 230 non-franchised offices, Aerotek serves 17,000 clients and 300,000 contract employees every year. To learn more, visit aerotek.com.
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