Leading consulting firm has an immediate need for a Director of Regulatory Affairs for their office in the metro Chicago area. This is a Temp to Perm position.
Responsibilities:
-> Manage and direct new and ongoing projects related to regulatory compliance matters
-> Participate in new business development initiatives
-> Ensure compliance wit applicable policies of the client, industry practices, and cGMP/ICH Regulations (GMP - Good Manufacturing Practices) (ICH ? International Conference on Harmonization)
-> Manage project delivery within scope, schedule, and budget, utilize client?s ERP system for project control efforts
-> Review and approve project status reports, timesheets, expense reports, cost summaries, and project invoices
-> Electronically submit information through the eCTD Gateway and manage approval processes
Requirements:
-> Advanced degree, PhD preferred, in a science or engineering field. RAC certification desired (Regulatory Affairs Certified)
-> 10-15 years of management experience in the pharmaceutical, biotech, and/or medical device industries
-> 3-5 years of experience in regulatory affairs department management
-> Ability to write complex technical reports and regulation position papers
-> Be proficient in Microsoft Office, including Word, Excel, PowerPoint, and Project
-> Knowledge of FDA and ICH regulations
Benefits:
-> Paid Vacation
-> 401K
-> Health Insurance, and more... Related Words: fda, gmp, ich, rac, ectd, business analyst, financial analyst, business support analyst, business systems analyst, partner, anderson consulting, computer sciences corporation, ernst, lybrand, deloitte, mckinsey, kpmg, marwick, cap gemini, waterhouse, mercer consulting, towers perrin, kearney, booz allen, arthur anderson, sema group, ibm consulting, american management systems, hewitt associates, watson wyatt worldwide, boston consulting, andersen consulting, computer sciences corporation, csc, cap gemini, sogeti, price waterhouse, arthur anderson, sema group, american management, bain & company, braxton associates, cleveland associates, touche, marwick, salmon, quantum, strategic decision, siar bossard, hay group, eds, electronic data systems, coopers, harbridge house, kurt salmon, lek partnership, mckinsey, stategic decisions, lek partnership, engineering degree, degree in engineering, bs degree, validation engineer, verification engineer, hospital, medical, clinic, healthcare, health care, patient care, managed care, rehabilitation, blue cross, physician, therapy, hmo, hbo, medaphis, first data, m.b.a, mba, masters business administration, masters of science, master of science, ms project, microsoft project, ms-project, m.s. project, phd, ph.d., phd, p.h.d., phd, ph.d, operations supervisor, operation supervisor, operations coordinator
http://www.thinkenergygroup.com/think.nsf/applynewexpress?openform&ParentUNID=BFC0B8FD01D6075C85257664006D58E7&frm=Nation&frm1=Nation
Think Energy Group
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