Virxsys Corporation - Director, Regulatory Affairs

Director, Regulatory Affairs

Scope of Position: This role directs all regulatory aspects of assigned projects across project lifecycle to accomplish filing of regulatory submissions and facilitate regulatory interactions and regulatory approvals. This role serves as the principal regulatory affairs liaison to FDA and other health authorities for assigned regulatory projects and provides regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study issues, logistics and operational recommendations for product development. Primary responsibilities include developing regulatory submission strategies in agreement with defined product development objectives. The preparation and submission of IND and marketing applications, as well as various amendments and supplements. Interacting directly with health authorities, including FDA, to facilitate assessment of regulatory applications, including evaluating Agency questions and developing appropriate responses. Organizing and managing meetings with Health Authority personnel to obtain commitments and agreements enabling rapid and compliant development of products.
Major Responsibilities: Provide oversight and coordination of preparation and timely submission of regulatory application documents (IND, CTA, BLA, etc) that are consistent with corporate strategy and timeliness. Provide regulatory advice on all aspects (CMC, pre-clinical, clinical post-approval activities) of drug development to the company. Provide strategic advice to the company for the development of regulatory strategies and issue resolution. Liaise with FDA and other regulatory agencies as primary company contact. Ensure company compliance with all applicable guidances, regulations and laws. Manage all regulatory activities for assigned projects, including representation on the project development teams as appropriate. Supervise regulatory document assembly, review and submission to regulatory agencies, while ensuring that the compilation and transmittal of regulatory submissions are completed within defined time schedules and meet established standards. Participate and represent Regulatory in meetings and interacting with members of all company project teams and sub-teams to convey regulatory requirements and develop a strategy to meet corporate goals. Communicate regulatory issues to functional areas and transmit regulatory concerns from functional areas to senior management. Assist in the establishment and maintenance of Regulatory Affairs operating procedures for the department.
Experience and Qualifications Requisite for Position: · At least 7 years of direct regulatory affairs experience. Strong knowledge of regulations/guidelines governing development of pharmaceuticals. Experience in effective communication with FDA and other regulatory agencies. Experience in international drug development and marketing; familiarity with multi-national development, registration and marketing requirements. Experience in and thorough understanding of GLP/GCP/GMP compliance issues. Excellent interpersonal skills. Detailed oriented. Excellent oral and written communication skills Ability to work well under pressure. Ability to handle multiple competing priorities.
Educational Requirements: · B.S. or M.S. Degree in Life Science or related field

Please email your CV with cover letter to employment@virxsys.com