Principal Specialist Regulatory Affairs

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 

• Analyzes 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/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles 

• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations 

• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy) 

• Negotiates with regulatory authorities on complex issues throughout the product lifecycle 

• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution 

• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures 

• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance 

• Provides strategic input and technical guidance on global regulatory requirements to product development terms 

• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions 

• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions 

• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans 

• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases 

• Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships 

• Provides regulatory guidance on strategy for proposed product claims/labeling 

• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims 

• Manages electronic (eCTD) and paper registration development 

• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions 

• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process 

• Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees 

Education / work experience 

• BS in Engineering, Science, or related Advanced degree desired or MS in Regulatory Science 

• Typically, a minimum of 9 relevant RA years' experience 

• RAC(s) desired 

Knowledge / competencies 

• Articulates the organization's strategic vision in a manner that enables others to execute plans, tactics, and actions 

• Continually identifies and informs appropriate individuals on emerging trends, opportunities, and threats 

• Leverages a well-grounded knowledge of applicable laws, regulations and policies to develop and execute plans and programs 

• Ensures strategies, analyses, and plans consider anticipated long-range requirements and are not just based on the current situation 

• Makes informed decisions based on business frameworks and tools and give consideration to risks tradeoffs, timing, and available resources 

• Proactively manages and monitors progress against desired outcomes including working with others to establish and adjust contingency plans, revising and adapting processes, communicating success and learning from mistakes 

• Demonstrates the ability to build agreement and acceptance through an ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructively 

• Continuously develops staff by making accurate assessments of individual's capabilities and performance, and providing feedback, coaching, guidance, and mentoring 

• Demonstrates sensitivity and understanding of cultural considerations when dealing with others 

• Embraces scrutiny and accepts feedback as opportunity to learn and improve 

• Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities