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 documents 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 5 years’ experience
* MS or RAC(s) preferred
Knowledge / Competencies:
* Strong project management, writing, coordination, and execution of regulatory items
* Emphasis on technical and scientific regulatory activities
* 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
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