Senior Regulatory Affairs Specialist

Hybrid Role - minimum of 3 days onsite required.

Key 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 (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 2 years’ experience
• MS or RAC(s) preferred

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
   

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