Job Description
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 technical and/or tactical 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 4 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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