I have a very urgent Direct Client requirement for *Sr. Manager, GRA CMC *in *Deerfield, IL**. *Please Let Me Know If you have available candidate, please reply with their word resume, location, rate and contact number.
*Please send me your resume at satya....@ngtechinc.com <satya....@ngtechinc.com>Job Title: Sr. Manager, GRA CMCLocation: Deerfield, ILDuration: 12 months* ACCOUNTABILITIES: Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities with minimal supervision. As a project team leader or member, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle. Independently Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirements. Represents RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities, as required. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Evaluates change proposals for regulatory impact and filing requirements Fosters constructive working relationships when interacting with internal and/or external colleagues. EDUCATION, BEHAVIOURAL COMPENTENCIES AND SKILLS: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 6 + years pharmaceutical Regulatory CMC experience. Alternatively, 4 + years pharmaceutical Regulatory CMC experience combined with 2+ years relevant pharmaceutical experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance) desired. Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams. Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance. Demonstrates leadership, problem-solving ability, flexibility and teamwork Exercises good judgement in elevating and communicating actual or potential issues to line management. Excellent written and oral communication skills required. Active participation in Agency/Industry groups/forums preferred. RAC certification desirable but not mandatory. Thanks *Satya Raj*|Next Generation Technology, Inc 116 S Arlington Heights Road, Arlington Heights, IL - 60005 224-764-8408 satya....@ngtechinc.com -- You received this message because you are subscribed to the Google Groups "SAP or Oracle Financials" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-or-oracle-financials+unsubscr...@googlegroups.com. To post to this group, send email to sap-or-oracle-financials@googlegroups.com. Visit this group at https://groups.google.com/group/sap-or-oracle-financials. For more options, visit https://groups.google.com/d/optout.
