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%

Principal Specialist Regulatory Affairs

Job Description