Stability, advancement opportunities, exciting and truly meaningful products to help mankind...... That is what this company can offer you. This Senior Manager/Associate Director, Regulatory Affairs will be the regulatory representative on Product Development Teams and will provide regulatory support and advice for the teams. Will facilitate regulatory strategy development and implementation for Product Development Teams, take the lead on regulatory submissions for product and provide authoring, review, and coordination for quality submissions to regulatory agencies. Will also prepare for meetings, teleconferences, and other communications with FDA (including read-ahead packages and/or other necessary documentation), educate teams regarding regulatory risks and implications for strategy and product development activities, and utilize technical knowledge and effectively apply regulations and guidelines to the product development process. Major Responsibilities and Duties: o Lead development of regulatory strategy for Product Development Teams o Monitor product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices o Manage and lead a group of regulatory professionals within the Regulatory department o Provide critical review of all documentation supporting regulatory applications o Lead preparation of regulatory submissions including pre-IND and formal meetings with FDA, INDs, Annual Reports, BLAs and BLA supplements, and routine correspondence o Plan, coordinate, prepare and lead meetings and tele- conferences with regulatory agencies o Monitor applicable current and new regulatory requirements o Interact with company partners and consultants for various regulatory matters as needed o Contribute the regulatory perspective as needed on government proposals and external due diligence activities SKILLS, EDUCATION, BACKGROUND AND EXPERIENCE • Advanced Degree (MS or PhD preferred) in a Biological Science. • 6+ years of industry experience in Regulatory Affairs. • Regulatory affairs experience in biologics required. • Vaccine and/or virology experience preferred. • Direct interaction experience with FDA required. send resumes to: sue.komers@eliteresourcesolutions.com |
Senior Manager/Associate Director, Regulatory Affairs Job #9168
Elite Resource Solutions, LLC
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