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Job #02959

About our client Our client specializes in clinical research and is an expert in a variety of areas including trial design, quality of life and health economics. Position Location Director of Regulatory Affairs California Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the company's Regulatory Affairs Department in operational regulatory services for domestic and international clinical projects 2) Maintain awareness of current regulatory standards related to clinical research and drug submissions 3) Provide regulatory consultancy to internal project teams and client entities 4) Evaluate the impact of clinical/regulatory changes on assigned projects as well as on the company’s business operations 5) Collaborate with sponsors, consultants and internal personnel on the designing, preparation, and assembly of regulatory documents 6) Ensure consistency in regulatory communications with FDA and international guidelines as well as with client-mandated or company SOPs 7) Provide department-specific and company-wide training in regulatory issues 8) Review project requests and provide direction, guidance and evaluation to subordinate staff 9) Support business development personnel in developing proposals for regulatory services Requirements 1) Bachelor's degree (advanced degree preferred) 2) Experience in managing offshore staff (India preferred) 3) 10+ years of experience in drug development or equivalent