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