Senior Regulatory Affairs Specialist

Work Flexibility: Not available<p></p><p></p><p><b><span>What you will do:</span></b></p><ul><li>Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies</li><li>Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance</li><li>Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions</li><li>Identifies requirements and potential obstacles for market access distribution (federal, <span>provincial/territorial</span> state, reimbursement, purchasing groups, etc.)</li><li>Assists in the development of regulatory strategy and updates strategy based upon regulatory changes</li><li>Evaluates proposed products for regulatory classification and jurisdiction</li><li>Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities</li><li>Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization</li><li>Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes</li><li>Negotiates with regulatory authorities throughout the product lifecycle</li><li>Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation</li><li>Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance</li><li>Assists other departments in the development of SOPs to ensure regulatory compliance</li><li>Provides regulatory input and technical guidance on global regulatory requirements to product development teams</li><li>Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations</li><li>Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations</li><li>Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions</li><li>Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships</li><li>Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process</li><li>Provides regulatory information and guidance for proposed product claims/labeling</li><li>Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims</li><li>Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines</li><li>Monitors the progress of the regulatory authority review process through appropriate communications with the agency</li><li>Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools</li><li>Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees<br/> </li></ul><p><b>What you will need:</b></p><ul><li>BS in Engineering, Science, or related degree; or MS in Regulatory Science</li><li>Typically a minimum of 2 years’ experience</li><li>MS or RAC(s) preferred</li><li>Project management, writing, coordination, and execution of regulatory items</li><li>Perform technical and scientific regulatory activities</li><li>Usually works with minimum supervision, conferring with superior on unusual matters</li><li>Assignments are broad in nature, requiring originality and ingenuity</li><li>Has some latitude for unreviewed action or decision<br/> </li></ul><p></p><p></p>Travel Percentage: None<p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p>