Director, Regulatory Affairs

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Job Description: Job Summary: We are currently seeking a Director, Regulatory Affairs in Edison, NJ. This position will effectively liaise, negotiate and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company’s growth, thereby accomplishing corporate goals. Responsibilities: Liaise, negotiate and orchestrate meetings and teleconferences with FDA; strategize and plan for FDA meetings; capture all communications via contact reports. Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format. Participate in global product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Mentor/instruct and provide guidance to direct reports (if applicable). Review and interpret regulatory guidelines. Review RA and related documents for approval. Continuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Education/Experience BS degree in chemistry, biology or other related scientific discipline required. Masters, PhD or PharmD highly desired. 10+ years in the pharmaceutical industry. 5+ years in global regulatory affairs, NDA, sNDA, BLA filing to FDA considered a plus Knowledge and support of electronic publishing, electronic submissions and global document management. Ability to manage and coordinate several global projects simultaneously. Ability to liaise, negotiate and interact with FDA and worldwide regulatory agencies; orchestrate meetings and teleconferences; document interactions between DS and FDA. Ability to provide managerial direction and regulatory guidance. Ability to build team relationships and interface in a global team environment at all levels of management. Good organizational, planning and multi-tasking abilities; good oral and written communication skills. An ability and understanding of where to seek regulatory information. A thorough understanding of the submission processes: complete IND/NDAs including supplements and amendments (coordinating, managing, preparation and assembly of its components, and publishing a final quality submission); IND/NDA annuals reports; adverse events. Strong interpersonal and team building skills; Comprehension of regulations and guidelines; comprehension of GMPs, GLPs and GCPs. Post Doctorate, Pharmaceutical Fellowship in Regulatory Affairs considered desirable. Daiichi Sankyo, Inc. is an Equal Opportunity Employer - M/F/D/V
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Research and Development

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