New job Manager, Regulatory Affairs in Gaithersburg, MD, send resumes to dan.wienczkowski@rightthinginc.com

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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Manager, Regulatory Affairs in Gaithersburg, MD, send resumes to dan.wienczkowski@rightthinginc.com Dan Wienczkowski, ACIR, CIR, CDR, CSSR, PRC posted a job: Manager, Regulatory Affairs in Gaithersburg, MD, send resumes to dan.wienczkowski@rightthinginc.com "Title: Manager, Regulatory Affairs Location MD, Gaithersburg Job Description - Responsible for collection, preparation and assembly of documentation required for Investigational New Drug Applications (IND), Investigational Medicinal Product Dossiers (IMPD) and Clinical Trial Applications (CTA) for biologic oncology products. - Responsible for supporting cross-functional activities pertaining to regulatory meetings, including the development of briefing documents and conduct of meeting rehearsals. - Proactively identifies potential regulatory issues and recommends solutions to Regulatory Affairs management. - Leads team(s) responsible for development of regulatory submissions within assigned product portfolio. Interacts with other project team members to ensure the timely preparation and receipt of information required for regulatory submissions. - Monitors related corporate activities for regulatory compliance, including nonclinical, clinical, research and development/manufacturing. - Conducts and analyzes regulatory research to understand past precedence and the current competitive landscape. - Evaluates and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labeling. - Identifies priorities and key issues in complex situations and solves these problems with minimal assistance. - Is conversant and able to influence colleagues in multiple scientific areas. - Educates internal stakeholders on implications of regulations. - Provides preparation and planning support for meetings with regulatory agencies. - Supports the preparation of responses to complex questions and comments from regulatory agencies. - Develops timeline for responding to inquiries from regulatory agencies and ensures issues are addressed in a timely manner. - Identifies and appropriately communicates potential risks. - Builds solid internal advocate network to drive outcomes (e.g. Clinical, CMC and Research). - Represent Regulatory Affairs on Project Development Teams (PDT) as assigned. Requirements: - 4 years in Regulatory Affairs with an additional 2 years in a related field of biopharmaceuticals or equivalent. Prior oncology and early development (IND filing) experience desired. - BS/MS in a scientific discipline. Please email your resume to - dan.wienczkowski@rightthinginc.com"

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