Principal Specialist Regulatory Affairs

Job description

Work Flexibility: Hybrid Principal RA Specialist: Scope of the role: Global: Position summary: Possesses and applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Key areas of responsibility: Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy Participates in advocacy activities of a more advanced strategic nature Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies Provides guidance to integrate regulatory considerations into global product entry and exit strategy Identifies regulatory pathways for initial product designs and provides input to internal stakeholders Analyze s the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territor...