About this role
Work Flexibility: Hybrid or Onsite
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
Travel Percentage: None