Areas of Responsibility:
• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
• 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 (Government, Central/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.
ISO9001, ISO13485, IVDR, CE certificate, CDSCO