Lead Specialist, Regulatory Affairs

Key Areas of Responsibility:

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies   
• Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature   
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
• Evaluates proposed products for regulatory classification and jurisdiction
• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization 
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
• Negotiates with regulatory authorities throughout the product lifecycle
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Assists other departments in the development of SOPs to ensure regulatory compliance
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
• Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
• Provides regulatory information and guidance for proposed product claims/labeling
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

Education / Work Experience:

• BS in Engineering, Science, or related degree; or MS in Regulatory Science                                    
• Typically a minimum of 6 years’ experience
• MS or RAC(s) preferred

Knowledge / Competencies:

• Technical and management skills and engaged in regulatory strategy and operations
• 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
• Under general supervision, plans, conducts and supervises assignments
• Reviews progress and evaluates results
• Recommends changes in procedures
• Operates with appreciable latitude for unreviewed action or decision
• Reviews progress with management
• May direct work of Specialist or Sr. Specialist
• Seeks out diverse ideas, opinion, and insights and applies them in the workplace
• Connects and relates well with people who think and act differently than oneself
• Embraces scrutiny and accepts feedback as opportunity to learn and improve
• Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
• Navigates the dynamics, alliances, and competing requirements of the organization or business
• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities