Lead Specialist, Regulatory Affairs

Work Flexibility: Hybrid or Onsite<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p><b>Key Areas of Responsibility:</b></p><ul><li>Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies   Participates in advocacy activities of a technical and/or tactical nature</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, provincial/territorial 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</li></ul><p></p><p><b>Education / Work Experience:</b></p><ul><li>BS in Engineering, Science, or related degree; or MS in Regulatory Science                 </li><li>Typically a minimum of 4 years’ experience</li><li>MS or RAC(s) preferred</li></ul><p></p><p><b>Knowledge / Competencies:</b></p><ul><li>Strong project management, writing, coordination, and execution of regulatory items</li><li>Emphasis on technical and scientific regulatory activities</li><li>Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, postmarketing surveillance/vigilance and distribution</li><li>Under general supervision, plans, conducts and supervises assignments</li><li>Reviews progress and evaluates results</li><li>Recommends changes in procedures</li><li>Operates with appreciable latitude for unreviewed action or decision</li><li>Reviews progress with management</li><li>May direct work of Specialist or Sr. Specialist</li><li>Seeks out diverse ideas, opinion, and insights and applies them in the workplace</li><li>Connects and relates well with people who think and act differently than oneself</li><li>Embraces scrutiny and accepts feedback as opportunity to learn and improve</li><li>Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources</li><li>Navigates the dynamics, alliances, and competing requirements of the organization or business</li><li>Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities<br /> </li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: None<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>