Direct Hire-Regulatory Affairs Manager

Kelly Scientific Resources is looking to fill a Direct placement position for an experienced Regulatory Affairs Manager in Marietta, PA. This client is known for highly competitive salaries and benefits, including health insurance plans, employee savings plans, etc. This incumbent will be responsible for the writing, assembling and review of all regulatory documents (CMC and facilities) for all products manufactured at Marietta. Acts as liaison with regulatory authorities and provides regulatory support for all site activities.Other Responsibilities include but are not limited to the following:- Responsible to maintain and update all regulatory documents for the site. Including building and equipment, in liaison with the local validation group, and to the chemistry, manufacturing and control (CMC) of vaccine manufactured in the formulation/filling/lyophilization facilities of the plant (Drug product manufacturing)- Responsible for preparation and quality of regulatory documents on products manufactured at Marietta (Both CMC and facilities sections) of clinical trial applications, INDs, Master Files, marketing authorizations.- Interfaces directly with governmental regulatory personnel in the US and EU/Int'l to facilitate the review and approval of regulatory applications.- Provides regulatory review of Master Batch records, change controls, SOP and other site documentation.- Partners with the central vaccine group in Rixensart for EU/Int'l or through USRA for submissions to the FDA.Education and Experience- BS or BA in a scientific background with a minimum of 4 years relevant experience working in regulatory affairs in a licensed biopharmaceutical or biological products facility.- Fully versed in regualtory and legislation guidelines (US and ICH) related to vaccines and building equipment. Including GMP's, FDA and other regulatory agency requirements sufficient to comply to quality operations and compliance. Kelly Scientific Resources is a highly specialized and rapidly expanding business unit of global staffing provider, Kelly Services, Inc. Kelly Scientific Resources leads the world in dedicated scientific and clinical research staffing, operating in 19 countries throughout North America, Europe, and the Pacific Rim. Since its launch in 1995, Kelly Scientific Resources has provided staffing and placement services to a broad spectrum of industries, including biotechnology, chemical, consumer products, cosmetics, environmental, food sciences, medical/clinical, pharmaceutical, and petrochemical. For more information, visit www.kellyscientific.com Learn more about company