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 current 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 wit