Senior Regulatory Affairs Specialist

Job description

Work Flexibility: Hybrid or Onsite (23 month fixed term contract) 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 regu...