REGULATORY TECHNICIAN SPECIALIST Job in Knoxville, Tennessee US

REGULATORY TECHNICIAN SPECIALIST

Company: Siemens Medical Solutions USA, Inc. Division: SMS - Molecular Imaging Location: TN - Knoxville Req ID: 109357 Position Title: REGULATORY TECHNICIAN SPECIALIST Experience Level: Mid Level Education Required: Bachelors Degree Travel Required: Yes Company Description: We are one of the largest global suppliers of healthcare equipment, renowned for innovative products, services and solutions including diagnostic imaging systems, therapy equipment for treatment and electromedicine and IT solutions to optimize workflow and increase efficiency in the healthcare industry. Siemens is an Equal Opportunity Employer encouraging diversity in the workplace. Job Description: Responsible for collection, preparation and assembly of documentation required for Investigational New Drug Applications (IND), Investigational Medicinal Product Dossiers (IMPD) and ANDAs * 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. * Participates in or assist senior regulatory associates in development of regulatory submissions within assigned products. Interacts with other project team members to ensure the timely preparation and receipt of information required for regulatory submissions. Interacts with internal and external partners as necessary to support product development. * 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. * Drives priorities and key issues as defined by regulatory management * Is conversant and able to influence colleagues in regulatory strategies and compliance issues * 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. Position Requirements: A minimum of 3-4 years in Regulatory Affairs with an additional 2 years in a related field of biopharmaceuticals or equivalent. Prior product development experience ( participaion in non-clinical or CMC IND /NDA filing) experience desired. Education: BS/MS in a scientific discipline. * High standard of professional ethics, integrity and trust. * Excellent oral and written communication skills. * Excellent planning, organizational and prioritizing skills. * Consistently high professional image and demeanor. * Strong interpersonal /group skills; capable of working collaboratively with colleagues in all functions. * Attention to detail and accuracy. * Able to effectively multi-task. * Ability to interpret, understand and comply with domestic and international regulatory requirements. * Ability to coordinate information from cross-functional disciplines. * Flexible in responding to changing project priorities. * Exercise good judgment in decision-making and sharing of sensitive information. * Strong understanding of the drug development and regulatory process. * Knowledgeable in the general principles of nonclinical development, chemistry/manufacturing and clinical development. * Flexibility to work on issues of diverse scope and apply knowledge gained to multiple tasks. * Responds effectively to meet management objectives. . Additional Information: Travel Percentage: 5%