Senior Regulatory Affairs Specialist - Product Environmental Compliance

Sr. RA Specialist- Product Environmental Compliance Work Flexibility: Hybrid What you will do- Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies and 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 and 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 and evaluates proposed products for regulatory classification and jurisdiction Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities and 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 and negotiates with regulatory authorities throughout the product lifecycle Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation and 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 and 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 and 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; regulatory information and guidance for proposed product claims/labeling Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process 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 and relevant a minimum of 2 years’ experience MS or RAC(s) preferred Experience - 5 years - 7 years Knowledge / Competencies: Project management, writing, coordination, and execution of regulatory items Perform technical and scientific regulatory activities Usually works with minimum supervision, conferring with superior on unusual matters Assignments are broad in nature, requiring originality and ingenuity Has some latitude for unreviewed action or decision Travel Percentage: 10% Experience Level Senior Level