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

• 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

Travel Percentage: 10%