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 legislationprocessesand procedures.

Key areas of responsibility

• Assesses links between globalsocietaland economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy

• Participates in advocacy activities of a more advancedstrategicnature

• Develops and updates globalregionaland multi-country regulatory strategy and aligns regulatory strategies to organizational strategies

• Provides guidance to integrate regulatory considerations into global product entry andexit strategy

• Identifiesregulatory pathways forinitialproduct designs and provides input to internal stakeholders

• Analyzesthe adequacy of proposed regulatory pathways and strategy forinitialproduct designs and recommends changes or refinements based oninitialregulatory outcomes

• Assesses all requirements and potential obstacles for market access and distribution (federal provincial/territorial/state reimbursementpurchasinggroups etc.) and develops solutions to addressanticipatedobstacles

• 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 toexpeditedevelopment 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

• Identifiesthe 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 strategiesrelativeto product and clinical safety issuesidentifiedduring clinical phases

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

• Providesregulatory 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 forappropriate internalreview 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 Scienceor related Advanced degree desired or MS in Regulatory Science

• Typicallya minimum of 9relevant RAyears experience

• RAC(s) desired

Knowledge / competencies

• Articulates the organizations strategic vision in a manner that enables others to execute plans tactics and actions

• Continuallyidentifiesand informsappropriate individualson emerging trends opportunities and threats

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

• Ensures strategies analyses and plans consideranticipatedlong-range requirements and are not just based on the current situation

• Makes informed decisions based on business frameworks and tools andgive consideration toriskstradeoffs timing and available resources

• Proactively manages and monitors progress against desired outcomes including working with others toestablishand adjust contingency plansrevisingand 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 makingaccurateassessments of individuals 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